Active Clinical Trials

SAVI-PCI is scheduled to begin enrolling patients in Spring 2012.

Read more on clinicaltrials.gov

This clinical trial will evaluate an investigational dosing regimen of Aggrastat, in a setting and patient population that is not approved by the FDA. Full Prescribing Information is available to Healthcare Professionals on the Aggrastat Product Website.

AGGRASTAT (tirofiban HCl)

Product History

Aggrastat was launched in 1998 and Medicure acquired the US product rights in 2006. Outside of the US, Aggrastat rights are owned by Iroko Cardio. Medicure is currently focused on clinical development and healthcare partnerships. Please contact an Aggrastat Product Specialist for more information on current Aggrastat initiatives.

Mechanism of Action


On an activated platelet thousands of GP IIb/IIIa receptors are exposed. Fibrinogen binds to these receptors, cross-linking platelets and creating thrombi (blood clots).

Aggrastat, a Glyco-Protein IIb/IIIa Inhibitor, blocks the GP IIb/IIIa receptor, preventing the binding of fibrinogen and reducing platelet aggregation by over 90%.

In addition to prevention, Aggrastat can also disaggregate pre-existing thrombus formations, helping to restore blood flow in affected arteries.

Key Product Characteristics

  • Small-molecule agent
  • Reversible onset of action
  • Greater than 90% platelet aggregation inhbition
  • Recommended by current ACC/AHA Guideline publications

Product Inquiries

Medical Information:

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Indications

AGGRASTAT (tirofiban HCI), in combination with heparin, is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. AGGRASTAT has been studied in a setting, as described in Clinical Trials, that included aspirin and heparin.

Contraindications

AGGRASTAT is contraindicated in patients with: known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm; a history of thrombocytopenia following prior exposure to AGGRASTAT; history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; history, symptoms or findings suggestive of aortic dissection; severe hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use of another parenteral GP llb/llla inhibitor; acute pericarditis

Warnings

Bleeding is the most common complication encountered during therapy with AGGRASTAT. Administration of AGGRASTAT is associated with an increase in bleeding events classified as both major and minor bleeding events by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. AGGRASTAT should be used with caution in patients with platelet count <150,000/mm3, in patients with hemorrhagic retinopathy, and in chronic hemodialysis patients. Because AGGRASTAT inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis. The safety of AGGRASTAT when used in combination with thrombolytic agents has not been established. During therapy with AGGRASTAT, patients should be monitored for potential bleeding. When bleeding cannot be controlled with pressure, infusion of AGGRASTAT and heparin should be discontinued.