Medicure Announces Completion of Enrollment for FABOLUS-FASTER, Phase 4 Clinical Trial of Aggrastat (Tirofiban Hydrochloride) Injection VS Kengreal (Cangrelor) in Patients Undergoing Percutaneous Coronary Intervention (PCI)
WINNIPEG, Dec. 12, 2019 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH), (OTC: MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the completion of the FABOLUS-FASTER Phase 4 trial, a randomized, open-label, multi-center trial assessing different regimens of intravenous platelet inhibitors, notably tirofiban (an IV GP IIb/IIIa inhibitor) and cangrelor (an IV P2Y12 inhibitor) in the early phase of primary PCI. The study enrolled 120 patients. Medicure expects to release top-line data in Q1 of 2020.
"We are very pleased with the completion of enrollment of FABOLUS-FASTER. Medicure is proud to support innovative and contemporary clinical research involving Aggrastat, in particular sponsoring leading cardiologists such as Dr. Marco Valgimigli", said Albert Friesen, PhD, CEO of Medicure.
Marco Valgimigli, MD, PhD, Professor of Cardiology, Director of Clinical Research at Bern University Hospital, and principle investigator for the trial, stated, "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."
FABOLUS-FASTER was funded by a grant from Medicure. This study does not imply comparable efficacy, safety, or product interchangeability. Please note that the use of Aggrastat in STEMI patients has not been approved by the FDA. As of this time, neither Aggrastat nor any of the GP IIb/IIIa inhibitors are indicated for the use in STEMI patients. Aggrastat is approved for use in NSTE-ACS patients. Refer to Important Safety Information below and the U.S. Prescribing Information for complete product information.
About Medicure Inc.
Important Safety Information for AGGRASTAT® (tirofiban hydrochloride)
Indications and Usage
Dosage and Administration
Warnings and Precautions
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AGGRASTAT® (tirofiban hydrochloride) is a registered trademark of Medicure International Inc.
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Company Codes: OTC-PINK:MCUJF, TorontoVE:MPH