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

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ClinicalTrials.gov Identifier: NCT00129805
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : August 19, 2008
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation

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.


Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: MCI-9042 Drug: Aspirin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : January 2001
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: MCI-9042 Drug: MCI-9042
Other Names:
  • Sarpogrelate(INN)
  • ANPLAG(R)

Active Comparator: Aspirin Drug: Aspirin



Primary Outcome Measures :
  1. recurrence of cerebral infarction

Secondary Outcome Measures :
  1. intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129805


Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Chair: Yukito Shinohara, MD Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Publications of Results:
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Responsible Party: General Manager, Clinical Research Department I, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00129805     History of Changes
Other Study ID Numbers: MCI9042-15
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: August 19, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
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Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Aspirin
Sarpogrelate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors