Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS・com)

This study is currently recruiting participants.
Verified December 2013 by Japan Cardiovascular Research Foundation
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Japan Cardiovascular Research Foundation
ClinicalTrials.gov Identifier:
NCT01995370
First received: November 15, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Noncardioembolic Cerebral Infarction
Drug: aspirin
Drug: clopidogrel
Drug: cilostazol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cilostazol Stroke Prevention Study for Antiplatelet Combination

Resource links provided by NLM:


Further study details as provided by Japan Cardiovascular Research Foundation:

Primary Outcome Measures:
  • Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
    An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.


Secondary Outcome Measures:
  • Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • SAH or ICH [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • IS or transient ischemic attack (TIA) [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Death from any cause [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • All vascular events: stroke, MI, and other vascular events [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Adverse events and adverse drug reactions [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
  • Severe or life-threatening hemorrhage (GUSTO Criteria) [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4000
Study Start Date: October 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Pletaal OD Tablet

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01995370

Contacts
Contact: Norio Aso +81-6-6872-0010 jcrf-csps@jcvrf.jp
Contact: Minoru Ido +81-6-4807-3015 prj-csps.cont.com@eps.co.jp

Locations
Japan
Japan Cardiovascular Research Foundation Recruiting
Osaka, Japan, 565-8565
Contact: Norio Aso    +81-6-6872-0010    jcrf-csps@jcvrf.jp   
Contact: Minoru Ido    +81-6-4807-3015    prj-csps.cont.com@eps.co.jp   
Principal Investigator: Takenori Yamaguchi         
Sponsors and Collaborators
Japan Cardiovascular Research Foundation
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Takenori Yamaguchi, President emeritus National Cerebral and Cardiovascular Center
  More Information

No publications provided

Responsible Party: Japan Cardiovascular Research Foundation
ClinicalTrials.gov Identifier: NCT01995370     History of Changes
Other Study ID Numbers: 021-TADD-1300-1, 000012180
Study First Received: November 15, 2013
Last Updated: December 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Cardiovascular Research Foundation:
Noncardioembolic cerebral infarction
Dual antiplatelet therapy (DAPT)
Cilostazol
Aspirin
Clopidogrel

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Aspirin
Cilostazol
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014