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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group L

25mg sarpogrelate

Group Type EXPERIMENTAL

MCI-9042

Intervention Type DRUG

group M

50mg sarpogrelate

Group Type EXPERIMENTAL

MCI-9042

Intervention Type DRUG

group H

100mg sarpogrelate

Group Type EXPERIMENTAL

MCI-9042

Intervention Type DRUG

Interventions

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MCI-9042

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No