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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00147303
First Posted: September 7, 2005
Last Update Posted: April 10, 2015
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.
Information provided by:
Mitsubishi Tanabe Pharma Corporation
  Purpose

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 Intervention Phase
Cerebral Infarction Drug: MCI-9042 Phase 3

Study Type: Interventional
Study Design: 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.

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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].

Enrollment: 46
Study Start Date: April 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group L
25mg sarpogrelate
Drug: MCI-9042
Experimental: group M
50mg sarpogrelate
Drug: MCI-9042
Experimental: group H
100mg sarpogrelate
Drug: MCI-9042

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT00147303


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

Publications:
Responsible Party: General Manager, Clinical Research Department I, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00147303     History of Changes
Other Study ID Numbers: MCI9042-17
First Submitted: September 4, 2005
First Posted: September 7, 2005
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
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
Sarpogrelate
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs