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

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 3

Conditions

Cerebral Infarction

Treatments

Drug: Aspirin

Drug: MCI-9042

Study type

Interventional

Funder types

Industry

Identifiers

NCT00129805

MCI9042-15

Details and patient eligibility

About

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.

Enrollment

1,510 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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