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NCT Number: NCT00147303

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

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCI-9042

Drug

Primary outcomes

  1. 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].

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 7, 2005
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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