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

August 18, 2008 updated by: Mitsubishi Tanabe Pharma Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1510

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aspirin
Drug: Aspirin
Experimental: MCI-9042
Drug: MCI-9042
Other Names:
  • Sarpogrelate(INN)
  • ANPLAG(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
recurrence of cerebral infarction

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Chair: Yukito Shinohara, MD, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

August 11, 2005

First Submitted That Met QC Criteria

August 11, 2005

First Posted (Estimate)

August 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 19, 2008

Last Update Submitted That Met QC Criteria

August 18, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI9042-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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