Status:

COMPLETED

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

Lead Sponsor:

Tanabe Pharma Corporation

Conditions:

Cerebral Infarction

Eligibility:

All Genders

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • Cerebral infarction except cardiac source of embolism based on the NINDSⅢclassification
  • Neurological signs persisting≧ 1 day from onset
  • Defined onset of symptoms, and stable condition at the period of enrollment
  • CT or MRI detection of responsible site
  • age≧20
  • Systolic pressure≦180 mmHg, Diastolic pressure≦110 mmHg
  • 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
  • Written informed consent must be obtained from the patients before enrollment into the study

Exclusion

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

Key Trial Info

Start Date :

April 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2005

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00147303

Start Date

April 1 2004

End Date

January 1 2005

Last Update

April 10 2015

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