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

Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00129805

Enrollment

1510

Registered

2005-08-12

Start date

2001-01-31

Completion date

2004-09-30

Last updated

2008-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

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.

Interventions

DRUGMCI-9042

DRUGAspirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
recurrence of cerebral infarction	—

Secondary

Measure	Time frame
intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026