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

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MCI-9042
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    group L

    group M

    group H

    Arm Description

    25mg sarpogrelate

    50mg sarpogrelate

    100mg sarpogrelate

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

    Full Information

    First Posted
    September 4, 2005
    Last Updated
    April 8, 2015
    Sponsor
    Mitsubishi Tanabe Pharma Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00147303
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    January 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mitsubishi Tanabe Pharma Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group L
    Arm Type
    Experimental
    Arm Description
    25mg sarpogrelate
    Arm Title
    group M
    Arm Type
    Experimental
    Arm Description
    50mg sarpogrelate
    Arm Title
    group H
    Arm Type
    Experimental
    Arm Description
    100mg sarpogrelate
    Intervention Type
    Drug
    Intervention Name(s)
    MCI-9042
    Primary Outcome Measure Information:
    Title
    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].

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shinichiro Uchiyama, MD
    Organizational Affiliation
    Tokyo Women's Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17622759
    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.
    Results Reference
    result

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

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