Aggrastat: Uses, Dosage & Side Effects
A glycoprotein IIb/IIIa receptor inhibitor used to prevent blood clots in acute coronary syndrome and during percutaneous coronary intervention (PCI)
Aggrastat (tirofiban) is a potent antiplatelet medication that belongs to the glycoprotein (GP) IIb/IIIa receptor inhibitor class. It is used in the hospital setting to prevent blood clot formation in patients experiencing acute coronary syndrome (ACS), including unstable angina and non-ST-elevation myocardial infarction (NSTEMI). Aggrastat works by reversibly blocking the GP IIb/IIIa receptor on activated platelets, which is the final common pathway for platelet aggregation. It is administered intravenously alongside aspirin and unfractionated heparin, and is particularly important in patients undergoing percutaneous coronary intervention (PCI) such as balloon angioplasty or coronary stent placement. This medication is only available by prescription and must be given under close medical supervision in a hospital environment.
Quick Facts: Aggrastat
Key Takeaways
- Aggrastat (tirofiban) is an intravenous antiplatelet drug that blocks platelet aggregation by inhibiting the GP IIb/IIIa receptor, the final common pathway for clot formation.
- It is used in acute coronary syndrome (unstable angina, NSTEMI) and during percutaneous coronary intervention (PCI) to prevent thrombotic complications.
- The most significant risk is bleeding, which can range from minor bruising to serious internal hemorrhage. Platelet counts must be monitored.
- Aggrastat is always given alongside aspirin and unfractionated heparin, and is administered exclusively in a hospital setting under specialist supervision.
- The dose must be reduced by 50% in patients with severe kidney impairment (creatinine clearance below 30 mL/min).
What Is Aggrastat and What Is It Used For?
Aggrastat contains the active substance tirofiban, a non-peptide antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor. This receptor plays a central role in platelet aggregation — the process by which blood platelets clump together to form clots. By reversibly blocking this receptor, tirofiban prevents fibrinogen and von Willebrand factor from cross-linking activated platelets, thereby powerfully inhibiting the formation of blood clots.
The primary clinical indication for Aggrastat is the prevention of early myocardial infarction (heart attack) in patients presenting with non-ST-elevation acute coronary syndrome (NSTE-ACS), which includes unstable angina and non-ST-elevation myocardial infarction (NSTEMI). These conditions occur when blood flow to the heart muscle is partially blocked, typically by a blood clot forming on a ruptured atherosclerotic plaque in a coronary artery. Left untreated, this can progress to a complete blockage and a full heart attack.
Aggrastat is also used in patients undergoing percutaneous coronary intervention (PCI), a procedure in which a cardiologist threads a catheter through the blood vessels to the heart and uses a balloon to open narrowed or blocked coronary arteries. A small metal mesh tube (stent) is often placed during this procedure to keep the artery open. PCI carries an inherent risk of triggering platelet activation and thrombus formation at the treatment site, and Aggrastat helps mitigate this risk.
It is important to understand that Aggrastat is not a standalone treatment. It is always used as part of a combination therapy regimen that includes acetylsalicylic acid (aspirin) and unfractionated heparin. Aspirin provides sustained antiplatelet activity through a different mechanism (irreversible inhibition of cyclooxygenase), while heparin acts on the coagulation cascade to prevent fibrin formation. Together, these three agents provide complementary protection against thrombotic events.
The clinical evidence supporting Aggrastat comes from large, randomized controlled trials including the landmark PRISM (Platelet Receptor Inhibition in Ischemic Syndrome Management) and PRISM-PLUS trials, which demonstrated significant reductions in the composite endpoint of death, myocardial infarction, and refractory ischemia in patients treated with tirofiban compared to heparin alone. More recent evidence from the On-TIME 2 trial showed that early initiation of high-dose bolus tirofiban before PCI in ST-elevation myocardial infarction (STEMI) patients was associated with improved myocardial reperfusion.
What Should You Know Before Taking Aggrastat?
Before receiving Aggrastat, your healthcare team will conduct a thorough evaluation of your medical history, current medications, and overall health status. Because tirofiban profoundly inhibits platelet function, the primary concern is the risk of bleeding. Several conditions represent absolute contraindications to its use, while others require careful risk-benefit assessment.
Contraindications
You must not receive Aggrastat if you have any of the following conditions:
- Allergy to tirofiban or any of the other ingredients in Aggrastat (sodium chloride, sodium citrate dihydrate, anhydrous citric acid, hydrochloric acid, sodium hydroxide, or water for injection).
- Active internal bleeding or any internal bleeding within the past 30 days.
- History of intracranial hemorrhage (bleeding inside the skull), brain tumor, or abnormal blood vessels in the brain (such as arteriovenous malformations or aneurysms).
- Severe uncontrolled high blood pressure (malignant hypertension), which greatly increases the risk of hemorrhagic complications.
- Low platelet count (thrombocytopenia) or known problems with blood clotting ability.
- Previous thrombocytopenia associated with tirofiban or another GP IIb/IIIa inhibitor (such as abciximab or eptifibatide).
- Stroke within the past 30 days or any history of hemorrhagic stroke.
- Major surgery or severe trauma within the past 6 weeks.
- Severe liver disease, which can impair the body's ability to produce clotting factors.
Warnings and Precautions
Even if you do not have an absolute contraindication, your doctor needs to know about certain conditions that may increase your risk of complications. Inform your healthcare team if you have or have had any of the following:
- Cardiopulmonary resuscitation (CPR), tissue biopsies, or procedures for kidney stones within the past two weeks.
- Serious injury or major surgery within the past three months.
- Stomach or intestinal ulcers within the past three months.
- Recent gastrointestinal bleeding, or blood in urine or stool within the past year.
- Recent spinal surgery or any spinal procedure.
- Symptoms of or history of aortic dissection (a tear in the wall of the aorta).
- Uncontrolled high blood pressure (hypertension).
- Inflammation of the membrane surrounding the heart (pericarditis).
- Inflammation of blood vessels (vasculitis).
- Problems with blood vessels at the back of the eye (retinal vascular disease).
- Current or recent treatment with blood-thinning or clot-dissolving medications.
- Kidney problems, as the dose may need to be reduced.
- A subclavian venous catheter (central line in the collarbone area) placed within the past 24 hours.
- Heart failure or very low blood pressure related to heart failure.
- Low red blood cell count (anemia) or low overall blood cell counts.
Tirofiban can cause a rapid and severe drop in platelet count (thrombocytopenia), sometimes within hours of the first dose. Platelet counts should be monitored before treatment, within 6 hours of initiating the infusion, and at least once daily during therapy. If your platelet count falls below 90,000/mm³, additional monitoring and possible dose adjustments are required. A drop below 50,000/mm³ may necessitate stopping the infusion.
Pregnancy and Breastfeeding
The safety of Aggrastat during pregnancy has not been adequately established in human studies. Animal reproduction studies are not always predictive of human response, and the potential risk to the developing fetus is unknown. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, you should discuss this with your doctor before receiving Aggrastat. The medication should only be used during pregnancy if the potential clinical benefit clearly justifies the potential risk to the fetus.
It is not known whether tirofiban passes into breast milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue breastfeeding or to withhold the drug, taking into account the importance of the medication for the mother's health. Given that Aggrastat is used in acute, life-threatening cardiovascular situations, the benefit to the mother is typically considered paramount.
Sodium Content
Aggrastat solution for infusion contains approximately 917 mg of sodium per 250 mL infusion bag. This should be taken into consideration by patients on a controlled sodium diet, particularly those with heart failure or kidney disease where sodium restriction is important. Your healthcare team will factor this sodium load into your overall fluid and electrolyte management plan.
How Does Aggrastat Interact with Other Drugs?
Drug interactions are a critical consideration with Aggrastat because it is a potent antiplatelet agent. Any medication that affects hemostasis (the body's ability to stop bleeding) can potentially enhance the bleeding risk when combined with tirofiban. Your healthcare team will carefully review all of your current medications before initiating Aggrastat therapy.
Aggrastat is specifically intended to be used in combination with unfractionated heparin and oral antiplatelet agents including aspirin. The combination of these three agents has been extensively studied in clinical trials and represents the standard of care. However, adding further anticoagulant or antiplatelet medications beyond this established regimen can significantly increase the risk of hemorrhagic complications.
Major Interactions
| Drug / Drug Class | Interaction Type | Clinical Significance |
|---|---|---|
| Warfarin and other vitamin K antagonists | Increased bleeding risk | Concurrent use significantly increases hemorrhagic risk. INR monitoring essential. |
| Thrombolytics (alteplase, tenecteplase, streptokinase) | Synergistic bleeding risk | Combining fibrinolytics with GP IIb/IIIa inhibitors dramatically increases major bleeding events. |
| Other GP IIb/IIIa inhibitors (abciximab, eptifibatide) | Additive platelet inhibition | Must not be combined. Excessive platelet inhibition causes uncontrollable bleeding. |
| Low molecular weight heparins (enoxaparin, dalteparin) | Increased anticoagulant effect | Aggrastat is indicated with unfractionated heparin only. LMWH substitution not established in trials. |
| Direct oral anticoagulants (rivaroxaban, apixaban, dabigatran) | Increased bleeding risk | Concurrent use increases hemorrhagic risk. Clinical judgment required. |
Other Interactions to Be Aware Of
| Drug / Drug Class | Interaction Type | Clinical Significance |
|---|---|---|
| NSAIDs (ibuprofen, naproxen, diclofenac) | Additive bleeding risk | NSAIDs impair platelet function and may increase gastrointestinal bleeding risk. |
| Clopidogrel, prasugrel, ticagrelor | Additive antiplatelet effect | Clopidogrel is commonly co-administered in clinical practice. Prasugrel and ticagrelor have not been evaluated in randomized trials with tirofiban. |
| SSRIs and SNRIs (sertraline, fluoxetine, venlafaxine) | Reduced platelet serotonin | Serotonin reuptake inhibitors may impair platelet function and slightly increase bleeding risk. |
| Diazepam | Physical incompatibility | Must not be administered through the same IV line as Aggrastat due to physical incompatibility. |
Aggrastat is compatible with the following intravenous medications and can be administered through the same infusion line: atropine sulfate, dobutamine, dopamine, epinephrine (adrenaline), furosemide, heparin, lidocaine, midazolam, morphine sulfate, nitroglycerin (glyceryl trinitrate), potassium chloride, propranolol, and famotidine. However, diazepam must not be given through the same line due to physical incompatibility.
What Is the Correct Dosage of Aggrastat?
Aggrastat must be prescribed and administered by a physician experienced in the treatment of acute coronary syndromes. The dosing regimen is weight-based and varies depending on whether the patient is undergoing early invasive management (PCI within 4 hours) or a more conservative early invasive strategy (angiography expected after 4–48 hours). In all cases, Aggrastat is given intravenously alongside unfractionated heparin and oral antiplatelet therapy.
Adults — PCI Within 4 Hours (High-Dose Bolus Regimen)
For patients with NSTE-ACS planned for PCI within 4 hours of diagnosis, or patients with acute ST-elevation myocardial infarction (STEMI) planned for primary PCI, the recommended dosing is:
High-Dose Bolus Regimen (PCI Within 4 Hours)
- Bolus: 25 micrograms/kg administered intravenously over 3 minutes
- Maintenance infusion: 0.15 micrograms/kg/min for 12–24 hours, up to a maximum of 48 hours
- Combined with: Unfractionated heparin (50–60 units/kg bolus, then approximately 1,000 units/hour titrated to aPTT) and oral antiplatelet agent (aspirin, and typically clopidogrel)
Adults — Conservative Strategy (Angiography After 4–48 Hours)
For patients with NSTE-ACS who are not expected to undergo angiography for at least 4 hours and up to 48 hours after diagnosis:
Standard Infusion Regimen (Conservative Strategy)
- Initial infusion: 0.4 micrograms/kg/min for 30 minutes
- Maintenance infusion: 0.1 micrograms/kg/min
- Duration: Minimum 48 hours maintenance. Continue during coronary angiography and for at least 12 hours (maximum 24 hours) after PCI if performed. Total treatment should not exceed 108 hours.
- Combined with: Unfractionated heparin and oral antiplatelet agent
Weight-Based Dosage Reference Table
| Weight (kg) | 25 mcg/kg Bolus (mL) | 0.15 mcg/kg/min Maintenance (mL/h) | 0.4 mcg/kg/min Initial 30 min (mL/h) | 0.1 mcg/kg/min Maintenance (mL/h) |
|---|---|---|---|---|
| 30–37 | 17 | 6 | 16 | 4 |
| 46–54 | 25 | 9 | 24 | 6 |
| 63–70 | 33 | 12 | 32 | 8 |
| 80–87 | 42 | 15 | 40 | 10 |
| 96–104 | 50 | 18 | 48 | 12 |
| 113–120 | 58 | 21 | 56 | 14 |
| 129–137 | 67 | 24 | 64 | 16 |
| 146–153 | 75 | 27 | 72 | 18 |
Elderly Patients
No dose adjustment is required for elderly patients based on age alone. However, elderly patients are more likely to have reduced kidney function and an increased baseline risk of bleeding, so careful monitoring and clinical judgment are essential. The prescribing physician should consider the patient's overall clinical status, including renal function, weight, and comorbidities when determining the appropriate dose.
Severe Kidney Impairment
For patients with severe kidney impairment (creatinine clearance below 30 mL/min), the dose of Aggrastat must be reduced by 50%. This applies to both the bolus dose and the maintenance infusion rate. Tirofiban is partially cleared by the kidneys, and reduced renal function leads to higher plasma concentrations and prolonged antiplatelet effect, increasing the risk of bleeding.
Children
The safety and efficacy of Aggrastat have not been established in pediatric patients. Use in children is not recommended. No clinical data are available to support dosing in this population. Acute coronary syndromes of the type treated with GP IIb/IIIa inhibitors are exceedingly rare in children.
Missed Dose
Since Aggrastat is administered as a continuous intravenous infusion under direct medical supervision in a hospital setting, the concept of a missed dose does not apply in the traditional sense. If the infusion is accidentally interrupted, your healthcare team will determine the appropriate course of action based on how long the interruption lasted and your clinical status.
Overdose
The dose of Aggrastat is carefully controlled by the medical team. However, an overdose could occur due to infusion rate errors. The primary symptom of overdosage is bleeding. If excessive bleeding occurs, the infusion should be stopped immediately. Because tirofiban has a relatively short half-life (approximately 2 hours), platelet function generally recovers within 4–8 hours after discontinuation. In severe cases, platelet transfusion may be considered. Tirofiban can also be removed by hemodialysis. If you notice any unusual bleeding while receiving Aggrastat, inform your healthcare team immediately.
What Are the Side Effects of Aggrastat?
Like all medicines, Aggrastat can cause side effects, although not everyone experiences them. Because tirofiban is a potent inhibitor of platelet function, the most significant risk is bleeding, which can occur at virtually any site in the body. The severity can range from trivial (minor bruising) to life-threatening (intracranial or retroperitoneal hemorrhage). Your medical team will monitor you closely during and after the infusion for any signs of bleeding.
If you experience any of the following symptoms while receiving Aggrastat, contact your healthcare team immediately:
- Signs of bleeding inside the skull: sudden severe headache, vision or hearing changes, difficulty speaking, numbness, or problems with movement or balance
- Signs of serious internal bleeding: coughing up blood, blood in urine or stool, abdominal pain and swelling
- Signs of severe allergic reaction: difficulty breathing, dizziness, widespread rash or hives, chest tightness
Very Common
May affect more than 1 in 10 patients
- Bleeding after surgical procedures
- Bleeding under the skin at injection sites or in muscle tissue, causing swelling (hematoma and ecchymosis)
- Small red or purple spots on the skin (petechiae)
- Occult (non-visible) blood in urine or stool
- Nausea or general feeling of being unwell
- Headache
Common
May affect up to 1 in 10 patients
- Visible blood in urine (hematuria)
- Coughing up blood (hemoptysis)
- Nosebleeds (epistaxis)
- Bleeding from gums and mouth
- Bleeding from punctured blood vessels (access site bleeding)
- Decreased red blood cell count (reduced hematocrit and hemoglobin)
- Reduced platelet count below 90,000/mm³ (thrombocytopenia)
- Fever
Uncommon
May affect up to 1 in 100 patients
- Gastrointestinal bleeding (bleeding in stomach or intestines)
- Bloody vomiting (hematemesis)
- Severely reduced platelet count below 50,000/mm³
Frequency Not Known
Reported in post-marketing surveillance
- Intracranial hemorrhage (bleeding inside the skull)
- Spinal epidural hematoma (blood collection pressing on spinal cord)
- Retroperitoneal hemorrhage (bleeding in the abdominal cavity)
- Pulmonary hemorrhage (bleeding into the lungs)
- Acute and/or severe thrombocytopenia with platelet count below 20,000/mm³
- Severe allergic reactions including anaphylaxis with chest tightness, rash, hives, and symptoms causing breathing difficulty and dizziness
- Fatal hemorrhage (extremely rare)
It is important to report suspected side effects after a medicine has been approved. This allows ongoing monitoring of the benefit-risk balance. Healthcare professionals and patients are encouraged to report adverse reactions to their national pharmacovigilance agency (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom).
How Should You Store Aggrastat?
As a hospital-administered medication, Aggrastat storage is managed by pharmacists and healthcare professionals rather than patients. However, understanding proper storage conditions is important for ensuring medication safety.
Aggrastat should be stored at room temperature, protected from light in its original foil packaging. The 250 mL Freeflex infusion bags are supplied in a protective foil overwrap that should remain sealed until immediately before use. The solution must not be frozen.
Before administration, the solution should be visually inspected for particulate matter and discoloration. Aggrastat should be a clear, colorless solution. If visible particles are present or the solution appears discolored, it must not be used and should be discarded according to local pharmaceutical waste regulations.
The medication should be used before the expiration date printed on the label and outer packaging. The expiry date refers to the last day of the stated month. Any unused product or waste material should be disposed of in accordance with local requirements for pharmaceutical waste. It should never be disposed of via household waste or wastewater systems.
Keep all medicines out of the sight and reach of children, even in hospital settings where the medication is stored in pharmacy areas.
What Does Aggrastat Contain?
Understanding the full composition of Aggrastat is important both for identifying potential allergies to excipients and for understanding the pharmaceutical formulation.
Active Ingredient
The active substance is tirofiban. Each 1 mL of the solution for infusion contains 56 micrograms of tirofiban hydrochloride monohydrate, which is equivalent to 50 micrograms of tirofiban as the free base. A complete 250 mL infusion bag therefore contains 12.5 mg of tirofiban (as 14 mg tirofiban hydrochloride monohydrate).
Inactive Ingredients (Excipients)
- Sodium chloride — provides isotonicity and contributes to the sodium content of the solution
- Sodium citrate dihydrate — acts as a buffering agent to maintain solution pH
- Anhydrous citric acid — pH adjustment agent
- Water for injections — the solvent vehicle
- Hydrochloric acid and/or sodium hydroxide — used for pH adjustment during manufacturing
Packaging
Aggrastat is available as a clear, colorless solution in 250 mL Freeflex infusion bags. The bags are made of non-PVC, colorless, multi-layer polyolefin film with a polyolefin-sealed injection port. Each bag is packaged in a protective foil overwrap. The product is available in pack sizes of 1 or 3 infusion bags, though not all pack sizes may be marketed in every country.
The marketing authorization holder is Advanz Pharma Limited, based in Dublin, Ireland. The medication is manufactured by Tjoapack Netherlands B.V. in Etten-Leur, the Netherlands.
Frequently Asked Questions About Aggrastat
Aggrastat (tirofiban) is used to prevent blood clots in patients with acute coronary syndrome (ACS), including unstable angina and non-ST-elevation myocardial infarction (NSTEMI). It is also used during percutaneous coronary intervention (PCI) — a procedure to open blocked coronary arteries using balloons and stents. Aggrastat blocks the GP IIb/IIIa receptor on platelets, preventing them from clumping together and forming dangerous clots. It is always given alongside aspirin and heparin in a hospital setting.
Aggrastat is given exclusively as an intravenous (IV) infusion in a hospital or cardiac catheterization laboratory. It is not available in oral or any other form. For patients undergoing early PCI, a bolus dose of 25 micrograms/kg is given over 3 minutes, followed by a continuous maintenance infusion. For patients managed conservatively, a 30-minute loading infusion is followed by a lower maintenance rate. The dose is calculated based on the patient's body weight and adjusted for kidney function.
The most common side effect is bleeding, which can occur at various sites. Very common effects (affecting more than 1 in 10 patients) include post-procedural bleeding, bruising at injection sites, small red skin spots (petechiae), hidden blood in urine or stool, nausea, and headache. Common effects (up to 1 in 10) include visible blood in urine, nosebleeds, gum bleeding, and reduced blood cell counts. Serious but less common effects include gastrointestinal bleeding and severe platelet count drops.
Aggrastat should not be used in patients with active internal bleeding, bleeding within the past 30 days, history of brain hemorrhage or brain tumor, severe uncontrolled high blood pressure, low platelet count, previous platelet reactions to similar drugs, stroke within 30 days (or any hemorrhagic stroke), major surgery or severe trauma within 6 weeks, or severe liver disease. Your doctor will carefully assess your medical history before prescribing this medication.
Aggrastat is specifically designed to be used together with unfractionated heparin and oral antiplatelet agents including aspirin. Most clinical studies have used aspirin combined with clopidogrel as the oral antiplatelet regimen. However, combining Aggrastat with other anticoagulants (such as warfarin, direct oral anticoagulants, or thrombolytics) or additional GP IIb/IIIa inhibitors significantly increases bleeding risk and should generally be avoided unless specifically directed by your cardiologist.
The safety of Aggrastat during pregnancy has not been established. It should only be used if the potential benefit to the mother clearly outweighs the risk to the fetus. Women who are pregnant, breastfeeding, or planning pregnancy should discuss this with their healthcare provider. It is also unknown whether tirofiban passes into breast milk, so breastfeeding decisions should be made in consultation with your doctor.
References
- European Medicines Agency (EMA). Aggrastat Summary of Product Characteristics (SmPC). Last updated 2025. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Aggrastat (tirofiban hydrochloride) Prescribing Information. Revised 2024. Available at: www.fda.gov
- Collet JP, Thiele H, Barbato E, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. European Heart Journal. 2021;42(14):1289-1367. doi:10.1093/eurheartj/ehaa575
- Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes. Journal of the American College of Cardiology. 2014;64(24):e139-e228. doi:10.1016/j.jacc.2014.09.017
- The PRISM-PLUS Study Investigators. Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-Q-wave myocardial infarction. New England Journal of Medicine. 1998;338(21):1488-1497. doi:10.1056/NEJM199805213382102
- The PRISM Study Investigators. A comparison of aspirin plus tirofiban with aspirin plus heparin for unstable angina. New England Journal of Medicine. 1998;338(21):1498-1505. doi:10.1056/NEJM199805213382103
- Van't Hof AW, Ten Berg J, Heestermans T, et al. Prehospital initiation of tirofiban in patients with ST-elevation myocardial infarction undergoing primary angioplasty (On-TIME 2): a multicentre, double-blind, randomised controlled trial. Lancet. 2008;372(9638):537-546. doi:10.1016/S0140-6736(08)61235-0
- Valgimigli M, Biondi-Zoccai G, Tebaldi M, et al. Tirofiban as adjunctive therapy for acute coronary syndromes and percutaneous coronary intervention: a meta-analysis of randomized trials. European Heart Journal. 2010;31(1):35-49. doi:10.1093/eurheartj/ehp376
- World Health Organization (WHO). Model List of Essential Medicines. 23rd List (2023). Available at: www.who.int
- British National Formulary (BNF). Tirofiban. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
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