Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
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|ClinicalTrials.gov Identifier: NCT00129805|
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : August 19, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Infarction||Drug: MCI-9042 Drug: Aspirin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1510 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||September 2004|
|Active Comparator: Aspirin||
- recurrence of cerebral infarction
- intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129805
|Study Chair:||Yukito Shinohara, MD||Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital|