CSPS・com: Cilostazol Stroke Prevention Study for Antiplatelet Combination

Sponsor
Japan Cardiovascular Research Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT01995370
Collaborator
Otsuka Pharmaceutical Co., Ltd. (Industry)
1,884
1
2
59.8
31.5

Study Details

Study Description

Brief Summary

To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1884 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Cilostazol Stroke Prevention Study for Antiplatelet Combination
Actual Study Start Date :
Dec 13, 2013
Actual Primary Completion Date :
Dec 7, 2018
Actual Study Completion Date :
Dec 7, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Monotherapy group

Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Drug: aspirin
Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Other Names:
  • Bayaspirin
  • Drug: clopidogrel
    Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    Other Names:
  • Plavix
  • Experimental: DAPT group

    Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

    Drug: aspirin
    Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    Other Names:
  • Bayaspirin
  • Drug: clopidogrel
    Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    Other Names:
  • Plavix
  • Drug: cilostazol
    Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    Other Names:
  • Pletaal OD Tablet
  • Outcome Measures

    Primary Outcome Measures

    1. Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours [every 6 months]

      An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.

    Secondary Outcome Measures

    1. Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] [every 6 months]

    2. SAH or ICH [every 6 months]

    3. IS or transient ischemic attack (TIA) [every 6 months]

    4. Death from any cause [every 6 months]

    5. Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death [every 6 months]

    6. All vascular events: stroke, MI, and other vascular events [every 6 months]

    7. Adverse events and adverse drug reactions [every 6 months]

    8. Severe or life-threatening hemorrhage (GUSTO Criteria) [every 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment

    • Patients with a responsible lesion identified by MRI

    • Patients aged 20 to 85 years old when providing informed consent

    • Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent

    • Patients meeting at least one of the following criteria a-c:

    1. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)

    2. at least 50% stenosis of an extracranial artery (the common carotid artery,internal carotid artery,vertebral artery,brachiocephalic artery,or subclavian artery)

    3. Two or more of the following risk factors

    • Aged 65 years or more

    • Diabetes mellitus

    • Hypertension

    • Peripheral arterial disease

    • Chronic kidney disease

    • History of IS (excluding the index IS for this study)

    • History of ischemic heart disease

    • Smoking (only current smokers)

    • Patients considered to be able to visit the study site for ambulatory care throughout the observation period

    • Patients who provided written informed consent

    Exclusion Criteria:
    • Patients with emboligenic heart disease

    • Patients taking any anticoagulant agents

    • Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker

    • Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period

    • Patients with a drug-eluting coronary stent implanted within one year

    • Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders

    • Patients with a history of hypersensitivity to cilostazol

    • Patients with congestive heart failure or uncontrolled angina pectoris

    • Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)

    • Patients with severe liver or renal dysfunction

    • Women who are pregnant, breast-feeding, or of child-bearing potential

    • Patients with a malignant tumor requiring treatment

    • Patients who are taking aspirin, and meet any of the following criteria:

    • History of hypersensitivity to aspirin or salicylic acid analogues

    • Current peptic ulcer

    • Aspirin-induced asthma or its history

    • Patients who are taking clopidogrel, and meet the following criterion:

    ・History of hypersensitivity to clopidogrel

    • Patients who are participating in any other clinical studies

    • Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Japan Cardiovascular Research Foundation Osaka Japan 565-8565

    Sponsors and Collaborators

    • Japan Cardiovascular Research Foundation
    • Otsuka Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Takenori Yamaguchi, President emeritus, National Cerebral and Cardiovascular Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Japan Cardiovascular Research Foundation
    ClinicalTrials.gov Identifier:
    NCT01995370
    Other Study ID Numbers:
    • 021-TADD-1300-1
    • 000012180
    First Posted:
    Nov 26, 2013
    Last Update Posted:
    Mar 28, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Japan Cardiovascular Research Foundation
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 28, 2019