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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188824
• Other study ID #: DMR99-IRB-137
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2010
• Last updated: September 30, 2013
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stroke

Intervention

Drug:
• Cilostazol
100 mg, bid p.o.

Other:
• placebo
1 tablet, bid

Locations

Country	Name	City	State
n/a

Sponsors (16)

Lead Sponsor

Collaborator

China Medical University Hospital

Cathay General Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, Chung Shan Medical University, E-DA Hospital, En Chu Kong Hospital, Far Eastern Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kuang Tien General Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Tri-Service General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for this study is slowdown of PAD progression based on ABI.		2 years	No
Secondary	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	Yes