The Efficacy and Safety of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD): Protocol of a Randomized, Double-Blind, Placebo-Controlled Multicenter Trial

2014 ◽  
Vol 10 (1) ◽  
pp. 123-127 ◽  
Author(s):  
Jiann-Shing Jeng ◽  
Yu Sun ◽  
Jiunn-Tay Lee ◽  
Ruey-Tay Lin ◽  
Chih-Hung Chen ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Peripheral Arterial Disease ◽  
Arterial Disease ◽  
Multicenter Trial ◽  
Efficacy And Safety ◽  
Stroke Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Peripheral Arterial

Abstract T P338: To Evaluate the Efficacy and Safety of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) Study: Methodology and Baseline Data

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Jiann-Shing Jeng ◽  
Li-Ming Lien ◽  
Sien-Tsong Chen ◽  
Chung Y. Hsu ◽  
Keyword(s):  
Diabetes Mellitus ◽  
Ischemic Stroke ◽  
Peripheral Arterial Disease ◽  
Carotid Stenosis ◽  
Smoking Habit ◽  
Arterial Disease ◽  
Stroke Patients ◽  
Vascular Events ◽  
Safety And Efficacy ◽  
Peripheral Arterial

Background and Purpose: Ischemic stroke often co-exists with peripheral arterial disease (PAD). Patients with polyvascular diseases carry higher risks of vascular events and death. We initiated a study to evaluate the safety and efficacy of cilostazol in ischemic Stroke patients with PAD (SPAD) and have been taking aspirin for stroke prevention. Methods: The SPAD study is a prospective, multicenter, national, double-blinded, placebo-controlled, randomized trial. Patients with previous ischemic stroke or TIA who have been taking aspirin (100 mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1.0 were randomized to the treatment group with cilostazol (200 mg/day) or the placebo group with a 1:1 basis. Each patient is periodically followed-up for one year. The primary endpoint of the study is the change in the ABI. The secondary endpoints are the change in the common carotid artery intima-media thickness (IMT); major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and all death; and the safety, including major bleeding events, hemorrhagic stroke, and any death. Results: From September, 2010 to July, 2012, a total of 800 patients (male, 59.9%; female, 40.1%; average age, 70.4±9.3 years) were enrolled in the SPAD study, including 722 (90.2%) with ischemic stroke or 78 (9.8%) with TIA. Several atherosclerotic risk factors were commonly seen in this study population, including hypertension (88%), diabetes mellitus (48%), hypercholesterolemia (54%), smoking habit (41%), and carotid stenosis (15%). The distribution of baseline ABI were 0.90-0.99 (n=294), 0.70-0.89 (n=371), and <0.70 (n=136). Patients with lower ABI were more frequently associated with old age, lower body mass index, smoking habit, diabetes mellitus, carotid stenosis ≥50%, and higher systolic blood pressure. Conclusions: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelets, aspirin plus cilostazol, in ischemic stroke patients with PAD. The trial findings are expected to help in choosing better strategy for prevention of vascular events in this polyvascular disease.

scholarly journals Prevalence of peripheral arterial diseases in patients with large artery ischemic stroke and its prognostic value

2020 ◽  
Vol 56 (1) ◽  
Author(s):  
Sherien Farag ◽  
Mahmoud Elbalkimy ◽  
Ahmed Elbassiouny ◽  
John George ◽  
Mai Fathy
Keyword(s):  
Ischemic Stroke ◽  
Peripheral Arterial Disease ◽  
Carotid Stenosis ◽  
Ankle Brachial Index ◽  
Arterial Disease ◽  
Stroke Recurrence ◽  
Large Artery ◽  
Stroke Patients ◽  
Peripheral Arterial Diseases ◽  
Peripheral Arterial

Abstract Background Peripheral artery disease (PAD) can be an important predictor of comorbid cerebrovascular disease (CVD). However, it is not sufficiently investigated or considered in the management and prevention of stroke. Objectives To study the prevalence of peripheral arterial disease in large artery ischemic stroke patients and its impact on prognosis. Methods This is a prospective cohort study. A total of 100 patients with large artery ischemic stroke were enrolled with assessment for signs of PAD; duplex on both lower limb arteries and measurement of ankle-brachial index (ABI), carotid duplex, and/or C.T angiography brain and neck and/or conventional angiography; functional assessment by NIHSS at days 0, 7, and 30; and follow-up for recurrence or death after 6 months. Results Peripheral arterial disease was found in 42% of cases. Fifty percent of patients with lower extremity arterial disease were asymptomatic. Fifty percent had significant carotid stenosis (stenosis > 50%), and 48% of patients with significant carotid stenosis had peripheral arterial disease. During our study, 8 cases had a recurrence of large artery ischemic stroke, and 5 cases (62.5%) had PAD. The recurrence rate of stroke was the highest in the asymptomatic PAD group with 19%. Conclusion The prevalence of PAD in large artery ischemic stroke patients is high. Asymptomatic PAD has a risk potential for large artery ischemic stroke recurrence and mortality more than symptomatic PAD and non-PAD patients.

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