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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00129805
First received: August 11, 2005
Last updated: August 18, 2008
Last verified: August 2008
History of Changes
  Purpose

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 Intervention Phase
Cerebral Infarction
 Drug: MCI-9042
Drug: Aspirin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • recurrence of cerebral infarction [ Designated as safety issue: No ]

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

Enrollment: 1510
Study Start Date: January 2001
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCI-9042 Drug: MCI-9042
Other Names:
  • Sarpogrelate(INN)
  • ANPLAG(R)
Active Comparator: Aspirin Drug: Aspirin

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129805

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

Publications:

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
Study First Received: August 11, 2005
Last Updated: August 18, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 16, 2013