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

Study Overview
=================
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.

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

Conditions
-----------------
Cerebral Infarction

Intervention / Treatment
-----------------
* Drug: MCI-9042


Participation Criteria
=================
Eligibility 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group L<br>25mg sarpogrelate | Drug: MCI-9042<br> <br> |
| Experimental: group M<br>50mg sarpogrelate | Drug: MCI-9042<br> <br> |
| Experimental: group H<br>100mg sarpogrelate | Drug: MCI-9042<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. |  |  |