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

April 8, 2015 updated by: Mitsubishi Tanabe Pharma Corporation

Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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].

Collaborators and Investigators

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

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Chair: Shinichiro Uchiyama, MD, Tokyo Women's Medical University

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

April 1, 2004

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

September 4, 2005

First Submitted That Met QC Criteria

September 4, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI9042-17

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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