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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 3

Conditions

Cerebral Infarction

Treatments

Drug: MCI-9042

Study type

Interventional

Funder types

Industry

Identifiers

NCT00147303
MCI9042-17

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

46 participants in 3 patient groups

group L
Experimental group
Description:
25mg sarpogrelate
Treatment:
Drug: MCI-9042
group M
Experimental group
Description:
50mg sarpogrelate
Treatment:
Drug: MCI-9042
group H
Experimental group
Description:
100mg sarpogrelate
Treatment:
Drug: MCI-9042

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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