Clinical trial NCT00147303: Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Dose-responsive Clinical Pharmacology Study
Official title: Effect of Sarpogrelate on Platelet Aggregation in Patients With Cerebral Infarction: Clinical-pharmacological Dose-response Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Infarction
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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].
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tokyo Women's Medical University
name: Shinichiro Uchiyama, MD
role: STUDY_CHAIR
References:
citation: Uchiyama S, Ozaki Y, Satoh K, Kondo K, Nishimaru K. Effect of sarpogrelate, a 5-HT(2A) antagonist, on platelet aggregation in patients with ischemic stroke: clinical-pharmacological dose-response study. Cerebrovasc Dis. 2007;24(2-3):264-70. doi: 10.1159/000105135. Epub 2007 Jul 4.