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Completed

NCT Number: NCT01995370

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

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Japan Cardiovascular Research Foundation

Osaka, 565-8565, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)
  • at least 50% stenosis of an extracranial artery (the common carotid artery,internal carotid artery,vertebral artery,brachiocephalic artery,or subclavian artery)
  • 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

Treatment and study plan

Aspirin

Drug

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

clopidogrel

Drug

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

Cilostazol

Drug

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

Primary outcomes

  1. Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours

    Time frame: every 6 months

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

Secondary outcomes

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

    Time frame: every 6 months

  2. SAH or ICH

    Time frame: every 6 months

  3. IS or transient ischemic attack (TIA)

    Time frame: every 6 months

  4. Death from any cause

    Time frame: every 6 months

  5. Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death

    Time frame: every 6 months

  6. All vascular events: stroke, MI, and other vascular events

    Time frame: every 6 months

  7. Adverse events and adverse drug reactions

    Time frame: every 6 months

  8. Severe or life-threatening hemorrhage (GUSTO Criteria)

    Time frame: every 6 months

Sponsors and collaborators

Lead sponsor

Japan Cardiovascular Research Foundation

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Acronym: CSPS・com

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2013
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.