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

Phase 3

Completed

• Conditions: Cerebral Infarction
• Interventions: Drug: MCI-9042

• Registration Number: NCT00147303
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2005-09-04
• Study First Submitted QC: 2005-09-04
• Study First Posted: 2005-09-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group L	MCI-9042	25mg sarpogrelate
group M	MCI-9042	50mg sarpogrelate
group H	MCI-9042	100mg sarpogrelate

Primary Outcome Measures

Name	Time	Method
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].