Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis

This study has been completed.
Sponsor:
Collaborators:
Foundation for Biomedical Research and Innovation
Neurology, Tokyo Women's Medical University, School of Medicine
Kobe City General Hospital
Tohoku University
Kyushu University
Department of Neurology, Saiseikai Central Hospital
China National Center for Cardiovascular Diseases
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00333164
First received: June 1, 2006
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200 chronic stroke patients with 50-99% stenosis, to be followed up for 2 years


Condition Intervention Phase
Cerebrovascular Disorders
Drug: Asprin, Cilostazol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis (CATHARSIS)

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Progression of intracranial arterial stenosis after two years

Secondary Outcome Measures:
  • Cardiovascular events (ischemic stroke, cardiac infarctin, and other vascular events ),
  • death (stroke death, vascular death except for stroke ),
  • serious adverse events, new silent brain infarcts, and degrees of activity of daily living.

Estimated Enrollment: 200
Study Start Date: May 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Intracraial arterial stenosis (IAS) is more common in Asia, including Japanese, than in Cocasian. Also, stroke recurrence rate is high in patients with such lesions, despite medical treatment. Accoding to the result of WASID (N Engl J Med 2005;352:1305-16), warfarin is not recommended because of the concern of safety (higher risk of intracranial hemorrhage and death when compared with aspirin), wheras the efficacy of aspirin is not enough in symptomatic IAS patients. Under these conditions, we planned to conduct a nationwide multi-center, open labelled, randomized controlled trial to compare the effect of aspirin plus cilostazol (phosphodiestrase type 3 inhibitor) and aspirin alone on the progression of IAS in 200 IAS patients with ischemic stroke after 2 weeks to 6 months of onset. Patients are randomly allocated to either of two groups. Aspirin 100mg/day plus cilostazol 200 mg/day is given to the 100 patients in one group, and aspirin 100 mg/day alone is given to 100 patients in another group.

Follow-up period is at least two years. The primary endpoint is progression of IAS on MRA at two years after randomization. The secondary endpoints are cardiovascular events (ischemic stroke, myocardial infarct, and other vascular events), death, serious adverse events, new silent brain infarcts, and activity of daily life. The purpose of this study is to establish the best medical treatment in symptomatic IAS patients. This study will also provide important information for the future randomized controlled study to compare medical treatment alone and intravascular intervetnion (PTA and/or stenting) in these patients.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) Ischemic stroke after two weeks to six months from onset,
  • (2) Responsible lesion identified on MRI,
  • ( 3) Intracranial arterial stenosis >50% on MRA in the territory of responsible lesion,
  • (4) Intracranial arterial stenosis in suproclinoid internal carotid arterry, M1 portion of midlle cerebral artery, or basilar artery,
  • (5) Age of 45 to 85 years,
  • (6) Able to visit out-patient clinic, and
  • (7) Written informed consent obtained from patient or family.

Exclusion Criteria:

  • (1) Patients with potential cardiac embolic sources,
  • (2) Patients receiving cilostazol,
  • (3) Patients on warfarin treatment,
  • (4) Patients in whom MRI cannot be perfomed,
  • (5) Patients in whom PTA or bypass surgery is planned,
  • (6) Patients with history of symptomatic intracranial hemorrhage, other hemorrhagic diseases (active peptic ulcer etc.), hemophilia or coagulation abnormalities,
  • (7) Patients with hypersensitivity to cilostazol or aspirin,
  • (8) Patients with congestive heart failure or uncontrollable angina pectoris,
  • (9) Patients with thrombocytopenia (<100,000/mm3),
  • (10) Patients with liver dysfunction (AST or ALT >100 IU/L),
  • (11) Patients with renal dysfunction (Creatinin >2.0 mg/dl),
  • (12) Patients who cannot to be followed up during the study period,
  • (13) Patients who are enrolled in other clinical trials, and
  • (14) Patients inadequate for this study by other reasons.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333164

Locations
Japan
Tokyo Women's Medical University School of Medicine
Shinjuku-ku, Tokyo, Japan, 162-8666
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Foundation for Biomedical Research and Innovation
Neurology, Tokyo Women's Medical University, School of Medicine
Kobe City General Hospital
Tohoku University
Kyushu University
Department of Neurology, Saiseikai Central Hospital
China National Center for Cardiovascular Diseases
Investigators
Principal Investigator: Shinichiro Uchiyama, M.D. PhD Department of Neurology, Tokyo Women's Medical University School of Medicine
Principal Investigator: Nobuyuki Sakai, M.D. PhD Kobe City General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00333164     History of Changes
Other Study ID Numbers: UHA STROKE04-01
Study First Received: June 1, 2006
Last Updated: August 2, 2012
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
intracranial arteriosclerosis
cilostazol
Platelete aggrigation inhibitors dual antiplatelet therapy
Drug therapy, combination
Clinical trials

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cilostazol
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014