Medicure Announces Early Completion of Enrollment for iSPASM
January 28, 2021 at 04:04 am IST
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Medicure Inc. announce the early completion of iSPASM, a randomized, double-blind, single-center, Phase 1/2a trial aimed at assessing the safety of long-term (7-day) use of AGGRASTAT® (tirofiban hydrochloride) injection (an intravenous GP IIb/IIIa inhibitor) vs. placebo in patients with aneurysmal subarachnoid hemorrhage (aSAH) (NCT03691727). The primary endpoint in the 30 patient study was hemorrhagic changes evident on head CT and/or MRI assessed by the rates of symptomatic and asymptomatic bleeding. iSPASM was funded by an unrestricted educational grant from Medicure. This study does not imply efficacy of AGGRASTAT® in patients with aSAH. Please note that the use of AGGRASTAT® in neurointerventions 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 stroke 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.
Medicure Inc. is a Canada-based pharmaceutical company. The Company is focused on the development and commercialization of therapies for the United States cardiovascular market. The focus of the Company is the marketing and distribution of AGGRASTAT (tirofiban hydrochloride) injection and ZYPITAMAG (pitavastatin) tablets in the United States, where they are sold through the Companyâs United States subsidiary, Medicure Pharma Inc. The Company also operates Marley Drug, Inc. (Marley Drug), a pharmacy located in North Carolina that offers an Extended Supply drug program serving all 50 states, Washington D.C. and Puerto Rico. Marley Drug is committed to improving the health status of its patients and the communities they serve while reducing overall health care costs for employers and other health care consumers. AGGRASTAT is indicated to reduce the rate of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).