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

This study is currently recruiting participants. (see Contacts and Locations)
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

November 15, 2013
December 3, 2013
October 2013
March 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01995370 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cilostazol Stroke Prevention Study for Antiplatelet Combination
Cilostazol Stroke Prevention Study for Antiplatelet Combination

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Noncardioembolic Cerebral Infarction
  • 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
  • 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.

    Interventions:
    • Drug: aspirin
    • Drug: clopidogrel
  • 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.

    Interventions:
    • Drug: aspirin
    • Drug: clopidogrel
    • Drug: cilostazol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
March 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
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
Japan
 
NCT01995370
021-TADD-1300-1, 000012180
Yes
Japan Cardiovascular Research Foundation
Japan Cardiovascular Research Foundation
Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Takenori Yamaguchi, President emeritus National Cerebral and Cardiovascular Center
Japan Cardiovascular Research Foundation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP