Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis

This study is ongoing, but not recruiting participants.

First Received on June 1, 2006. Last Updated on July 25, 2011 History of Changes

Sponsor:	Translational Research Informatics Center, Kobe, Hyogo, Japan
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

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 III

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:

Drug Information available for: Cilostazol

U.S. FDA Resources

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
Estimated Study Completion Date:	March 2012
Estimated 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

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:	July 25, 2011
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
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012