December 12, 2019
Medicure Completes Enrollment in FABOLUS-FASTER Trial of Aggrastat in Patients Undergoing PCI
December 12, 2019—Medicure Inc. announced the completion of the FABOLUS-FASTER phase 4 trial of Aggrastat (tirofiban hydrochloride) injection versus Kengreal (cangrelor; The Medicines Company) in patients undergoing percutaneous coronary intervention (PCI).
FABOLUS-FASTER, which enrolled 120 patients, is a randomized, open-label, multicenter trial assessing different regimens of intravenous (IV) platelet inhibitors, notably tirofiban (an IV glycoprotein IIb/IIIa inhibitor) and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. Medicure expects to release top-line data in Q1 of 2020. FABOLUS-FASTER does not imply comparable efficacy, safety, or product interchangeability, advised the company.
The trial’s Principle Investigator, Marco Valgimigli, MD, commented in the company’s announcement, "We are extremely proud to have reached the completion of patient inclusion in this trial, which we believe, will be very informative for clinicians as it will provide unique comparative data regarding the potency and consistency of platelet inhibition among STEMI patients across available antiplatelet treatment options." Dr. Valgimigli is Professor of Cardiology and Director of Clinical Research at Bern University Hospital in Bern, Switzerland.
Medicure’s Aggrastat is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non–ST-elevation acute coronary syndrome.
The company advised that use of Aggrastat in patients with ST-elevation myocardial infarction (STEMI) has not been approved by the FDA. Currently, neither Aggrastat nor any of the glycoprotein IIb/IIIa inhibitors are indicated for the use in STEMI patients.