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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147303

Enrollment

Registered

2005-09-07

Start date

2004-04-30

Completion date

2005-01-31

Last updated

2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

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.

Interventions

DRUGMCI-9042

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	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].	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026