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

NCT ID: NCT00129805

Last Updated: 2008-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2004-09-30

Brief Summary

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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

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Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MCI-9042

Group Type EXPERIMENTAL

MCI-9042

Intervention Type DRUG

Aspirin

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Interventions

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MCI-9042

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Other Intervention Names

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Sarpogrelate(INN) ANPLAG(R)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Mitsubishi Tanabe Pharma Corporation

Principal Investigators

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Yukito Shinohara, MD

Role: STUDY_CHAIR

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

References

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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 in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.

Reference Type RESULT
PMID: 18388340 (View on PubMed)

Other Identifiers

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MCI9042-15

Identifier Type: -

Identifier Source: org_study_id