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Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

Primary Purpose

Cerebral Infarction

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

About this trial

This is an interventional prevention trial for Cerebral Infarction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cerebral infarction except cardiac source of embolism Onset ≧ 1 week to ≦ 6 months before randomization Neurological signs persisting ≧ 1 day from onset Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site Age ≧ 20 years Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg Exclusion Criteria: Functional outcome at randomization: Modified Rankin Scale = 4, 5 Previous or planned vascular surgery for cerebral infarction History of intracranial hemorrhage History of systemic bleeding, or other history of bleeding diathesis or coagulopathy Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.) Pregnant or possibly pregnant women, or nursing mothers History of sarpogrelate and aspirin sensitivity Treating malignant tumor or treated within 5 years Current peptic ulceration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MCI-9042

    Aspirin

    Arm Description

    Outcomes

    Primary Outcome Measures

    recurrence of cerebral infarction

    Secondary Outcome Measures

    intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death

    Full Information

    First Posted
    August 11, 2005
    Last Updated
    August 18, 2008
    Sponsor
    Mitsubishi Tanabe Pharma Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00129805
    Brief Title
    Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
    Official Title
    Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    September 2004 (Actual)
    Study Completion Date
    September 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Mitsubishi Tanabe Pharma Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease. S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.

    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
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1510 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MCI-9042
    Arm Type
    Experimental
    Arm Title
    Aspirin
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MCI-9042
    Other Intervention Name(s)
    Sarpogrelate(INN), ANPLAG(R)
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Primary Outcome Measure Information:
    Title
    recurrence of cerebral infarction
    Secondary Outcome Measure Information:
    Title
    intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Cerebral infarction except cardiac source of embolism Onset ≧ 1 week to ≦ 6 months before randomization Neurological signs persisting ≧ 1 day from onset Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site Age ≧ 20 years Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg Exclusion Criteria: Functional outcome at randomization: Modified Rankin Scale = 4, 5 Previous or planned vascular surgery for cerebral infarction History of intracranial hemorrhage History of systemic bleeding, or other history of bleeding diathesis or coagulopathy Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.) Pregnant or possibly pregnant women, or nursing mothers History of sarpogrelate and aspirin sensitivity Treating malignant tumor or treated within 5 years Current peptic ulceration
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yukito Shinohara, MD
    Organizational Affiliation
    Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18388340
    Citation
    Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.
    Results Reference
    result

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    Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

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