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

Phase 3

Completed

• Conditions: Cerebral Infarction
• Interventions: Drug: MCI-9042; Drug: Aspirin

• Registration Number: NCT00129805
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2005-08-11
• Study First Submitted QC: 2005-08-11
• Study First Posted: 2005-08-12
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-18
• Last Update Posted: 2008-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1510

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCI-9042	MCI-9042	-
Aspirin	Aspirin	-

Primary Outcome Measures

Name	Time	Method
recurrence of cerebral infarction

Secondary Outcome Measures

Name	Time	Method
intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death