Status:
COMPLETED
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Cerebral Infarction
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Cerebral infarction except cardiac source of embolism
- Onset ≧ 1 week to ≦ 6 months before randomization
- Neurological signs persisting ≧ 1 day from onset
- Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
- Age ≧ 20 years
- Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg
Exclusion
- Functional outcome at randomization: Modified Rankin Scale = 4, 5
- Previous or planned vascular surgery for cerebral infarction
- History of intracranial hemorrhage
- History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
- Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
- Pregnant or possibly pregnant women, or nursing mothers
- History of sarpogrelate and aspirin sensitivity
- Treating malignant tumor or treated within 5 years
- Current peptic ulceration
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
1510 Patients enrolled
Trial Details
Trial ID
NCT00129805
Start Date
January 1 2001
End Date
September 1 2004
Last Update
August 19 2008
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