Clinical Trial: Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Cont

Brief Summary:

Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.

S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.

Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation

Current Primary Outcome: recurrence of cerebral infarction

Original Primary Outcome: recurrent of cerebral infarction

Current Secondary Outcome: intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death

Original Secondary Outcome: Same as current

Information By: Mitsubishi Tanabe Pharma Corporation

Dates:
Date Received: August 11, 2005
Date Started: January 2001
Date Completion:
Last Updated: August 18, 2008
Last Verified: August 2008