The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients With Peripheral Arterial Disease (SPAD Study)

The purpose of this study is to investigate the Safety and Efficacy of Cilostazol in slowing down the progression of peripheral arterial disease (PAD) in ischemic stroke patients with PAD in Taiwan.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Cilostazol; Other: placebo

Detailed Description

One thousand patients will be randomized to take cilostazol (500 patients) or placebo (500 patients) in parallel groups. Patients will be screened and evaluated on Visits 1 to assess their eligibility prior to randomization. The treatment period (Visit 1-6) will last 12 months and the patient will receive initial and follow-up evaluation (section 4.5) including history and physical examinations, and baseline and end of treatment ABI and carotid IMT assessments. Vascular events and death as well as adverse events including bleeding complications will also be recorded at intervals as detailed in section 4.5.

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients, age ≧50 years; for female patients, postmenopausal (defined as at least 2 years without menses) has to be confirmed.
• Ischemic stroke or transient ischemic attack patients who have been taking aspirin 100 mg, QD
• Neurologically and clinically stable at inclusion
• PAD (i.e. ankle-brachial index or ABI <1.0)

Exclusion Criteria:

• Patients unable to give informed consent
• Patients with history of any type of hemorrhagic stroke (intracerebral hemorrhage,subarachnoid hemorrhage, or others)
• Modified Rankin Scale >4
• Patients with history of dementia requiring institutional care
• Known brain tumor
• Known anemia (defined as hemoglobin <10.0 g/dL)
• Known thrombocytopenia (defined as platelet count below 100,000/cm3)
• AST or ALT > 3 x Upper Normal Limit
• Calculated creatinine clearance < 30 ml/min according to the Copckroft formula)
• Known hemostasis or coagulation disorder
• Congestive heart failure, defined as a previous definitive diagnosis, or present symptoms of at least Category II of the NYHA classification system for CHF
• Revascularization of the lower limb arteries including bypass surgery, endovascular procedures
• Symptomatic PAD requiring treatment with cilostazol
• Known stenosis of the upper limb arteries that may affect the documentation of ABI
• Patients with known hypersensitivity to cilostazol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cilostazol; Pletaal® (Cilostazol) 100 mg, bid p.o.	Drug: Cilostazol; 100 mg, bid p.o.; Other Names: Pletaal®
PLACEBO_COMPARATOR: placebo; Placebo 1 tablet, bid p.o.	Other: placebo; 1 tablet, bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint for this study is slowdown of PAD progression based on ABI.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid intima-media thickness	Carotid intima-media thickness.; Vascular events, including recurrent stroke, myocardial infarction, unstable angina,other vascular events, and all death.; Safety, including major bleeding events, hemorrhagic stroke, any death.	2 years

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: National Taiwan University Hospital; Mackay Memorial Hospital; Shin Kong Wu Ho-Su Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; Taipei Veterans General Hospital, Taiwan; National Cheng-Kung University Hospital; Far Eastern Memorial Hospital; Tri-Service General Hospital; Changhua Christian Hospital; E-DA Hospital; Chi Mei Medical Hospital; Cathay General Hospital; Kuang Tien General Hospital; Chung Shan Medical University; En Chu Kong Hospital
• Investigators: Principal Investigator: Chung Y. Hsu, MD. Ph.D., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (ESTIMATE): August 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2013
• Last Update Submitted That Met QC Criteria: September 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Cerebral Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: DMR99-IRB-137