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Completed

NCT Number: NCT00234065

Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
  • Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
  • Patients aged 20 to 80 years (inclusive) at time of consent
  • Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
  • Patients without asymptomatic cerebral infarction
  • Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
  • Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion criteria

  • Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
  • Pregnant, possibly pregnant, or nursing women
  • Patients with ischemic heart failure
  • Patients with peptic ulcer
  • Patients with severer blood disorders
  • Patients with severe hepatic or renal
  • Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
  • Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
  • Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
  • Patients who are being treated with ticlopidine hydrochloride
  • Patients who are participating in another study for an investigational drug
  • Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Treatment and study plan

Cilostazol

Drug

oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years

Aspirin

Drug

oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

Primary outcomes

  1. Numbers of Patients With First Occurence of Stroke

    Time frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])

    The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.

Secondary outcomes

  1. Number of Patients With First Recurrence of Cerebral Infarction

    Time frame: From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

  2. Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease

    Time frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

    The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction or the first occurrence of transient ischaemic attack. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.

  3. Number of Deaths From Any Cause

    Time frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

    Number of deaths from any cause. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.

  4. Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events

    Time frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

    The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage, subarachnoid haemorrhage, transient ischaemic attack, angina pectris, myocardial infarction, heart failure, or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.

Other outcomes

  1. Number of Patients With First Occurrence of Haemorrhagic Event

    Time frame: From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

    The endpoint in this measure is a composite endpoint of the first occurrence of cerebral haemorrhage, subarachnoid haemorrhage or haemorrhage requiring hospital admission. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Post-marketing Study of Cilostazol: Study to Confirm Efficacy in Preventing Recurrent Cerebral Infarction in Comparison With Aspirin

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Oct 6, 2005
Registry last updated
Jun 10, 2011

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.

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