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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129805
• Other study ID #: MCI9042-15
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2005
• Last updated: August 18, 2008
• Start date: January 2001
• Est. completion date: September 2004

Study information

• Verified date: August 2008
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1510
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• MCI-9042

• Aspirin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

References & Publications (1)

Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of cerebral infarction			No
Secondary	intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death