Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147303
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : April 10, 2015
Information provided by:
Mitsubishi Tanabe Pharma Corporation

Brief Summary:

Sarpogrelate is an antiplatelet agent that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.

The present double-blind controlled clinical pharmacology study was performed on 45 patients with cerebral infarction, who were given 75, 150, or 300 mg three times daily of sarpogrelate for 7 days in order to evaluate the dose-response relationship in terms of the precisely measured inhibition of platelet aggregation.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.
Study Start Date : April 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Arm Intervention/treatment
Experimental: group L
25mg sarpogrelate
Drug: MCI-9042
Experimental: group M
50mg sarpogrelate
Drug: MCI-9042
Experimental: group H
100mg sarpogrelate
Drug: MCI-9042

Primary Outcome Measures :
  1. The maximum intensity of platelet aggregation on the last day of medication and as post-treatment percentage inhibition of the maximum intensity of platelet aggregation at baseline [(baseline - post-treatment )/baseline × 100 in each subject].

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification
  2. Neurological signs persisting≧ 1 day from onset
  3. Defined onset of symptoms, and stable condition at the period of enrollment
  4. CT or MRI detection of responsible site
  5. age≧20
  6. Systolic pressure≦180 mmHg, Diastolic pressure≦110 mmHg
  7. The maximum intensity of platelet aggregation is above 15 % induced by serotonin (1µM) and epinephrine (3µM) on the day of prior to the first medication
  8. Written informed consent must be obtained from the patients before enrollment into the study

Exclusion Criteria:

  1. Functional outcome at randomization: Modified Rankin Scale=4, 5
  2. Previous or planned for vascular surgery to cerebral infarction
  3. History of intracranial hemorrhage
  4. History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
  5. With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on )
  6. Treating malignant tumor
  7. Pregnant or possibly pregnant women, or nursing mothers
  8. History of sarpogrelate sensitivity
  9. Previously entered in other clinical trials within 3 months
  10. Less than 3 months since any other clinical trial
  11. Judged by investigator to be unsuitable for the study

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 identifier (NCT number): NCT00147303

Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Study Chair: Shinichiro Uchiyama, MD Tokyo Women's Medical University

Publications of Results:
Responsible Party: General Manager, Clinical Research Department I, Mitsubishi Tanabe Pharma Corporation Identifier: NCT00147303     History of Changes
Other Study ID Numbers: MCI9042-17
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Cerebral Infarction
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs