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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Aspirin; Sarpogrelate

Criteria

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