Trial | NCT00147303  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    46
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 Started
Apr 30
2004
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Apr 10
2015
Estimate

Drug MCI-9042

group L Experimental

25mg sarpogrelate

group M Experimental

50mg sarpogrelate

group H Experimental

100mg sarpogrelate

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted