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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147303
• Other study ID #: MCI9042-17
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2005
• Last updated: April 8, 2015
• Start date: April 2004
• Est. completion date: January 2005

Study information

• Verified date: April 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Cerebral infarction except cardiac source of embolism based on the NINDS?classification

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• MCI-9042

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

References & Publications (1)

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. Epub 2007 Jul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].