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

SPAD Study Investigators

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Abstract

Rationale: It is not uncommon for patients with ischemic stroke to have peripheral arterial disease (PAD). Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death. More effective regimens, such as dual antiplatelet agents, may be more effective for controlling progression of atherosclerosis in secondary prevention. Aim: This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack (TIA) who also have peripheral arterial disease. Design: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) study is a randomized double-blinded placebo-controlled trial. Patients with previous ischemic stroke or TIA who had been taking aspirin (100mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1·0 will be randomized into the treatment group with cilostazol (200mg/day) or the placebo group on 1:1 basis. Study outcomes: Patients will be evaluated at 1, 3, 6, 9 and 12 months after randomization. The primary endpoint is difference in change in ABI between groups. The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness (IMT) and incidence rate of major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and death; and the safety measures, including major bleeding events, hemorrhagic stroke and death of any cause. Conclusion: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents, aspirin plus cilostazol, in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD. Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD.

Original languageEnglish
Pages (from-to)123-127
Number of pages5
JournalInternational Journal of Stroke
Volume10
Issue number1
DOIs
Publication statusPublished - 2015 Jan 1

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Peripheral Arterial Disease
Multicenter Studies
Stroke
Placebos
Safety
Aspirin
Transient Ischemic Attack
Atherosclerosis
Ankle Brachial Index
Platelet Aggregation Inhibitors
Blood Vessels
cilostazol
Carotid Intima-Media Thickness
Unstable Angina
Random Allocation
Secondary Prevention
Cause of Death
Lower Extremity
Myocardial Infarction
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Neurology

Cite this

@article{9d71835f53e8438888411451ba9d406e,
title = "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",
abstract = "Rationale: It is not uncommon for patients with ischemic stroke to have peripheral arterial disease (PAD). Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death. More effective regimens, such as dual antiplatelet agents, may be more effective for controlling progression of atherosclerosis in secondary prevention. Aim: This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack (TIA) who also have peripheral arterial disease. Design: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) study is a randomized double-blinded placebo-controlled trial. Patients with previous ischemic stroke or TIA who had been taking aspirin (100mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1·0 will be randomized into the treatment group with cilostazol (200mg/day) or the placebo group on 1:1 basis. Study outcomes: Patients will be evaluated at 1, 3, 6, 9 and 12 months after randomization. The primary endpoint is difference in change in ABI between groups. The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness (IMT) and incidence rate of major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and death; and the safety measures, including major bleeding events, hemorrhagic stroke and death of any cause. Conclusion: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents, aspirin plus cilostazol, in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD. Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD.",
author = "{SPAD Study Investigators} and Jeng, {Jiann Shing} and Yu Sun and Lee, {Jiunn Tay} and Lin, {Ruey Tay} and Chen, {Chih Hung} and Po, {Helen L.} and Lin, {Huey Juan} and Liu, {Chung Hsiang} and Sun, {Ming Hui} and Sun, {Mu Chien} and Chern, {Chang Ming} and Lien, {Li Ming} and Chiu, {Hou Chang} and Hu, {Han Hwa} and Chiou, {Hung Yi} and Chen, {Sien Tsong} and Henry Ma and Hsu, {Chung Y.}",
year = "2015",
month = "1",
day = "1",
doi = "10.1111/ijs.12384",
language = "English",
volume = "10",
pages = "123--127",
journal = "International Journal of Stroke",
issn = "1747-4930",
publisher = "Wiley-Blackwell",
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}

TY - JOUR

T1 - The efficacy and safety of cilostazol in ischemic stroke patients with peripheral arterial disease (SPAD)

T2 - Protocol of a randomized, double-blind, placebo-controlled multicenter trial

AU - SPAD Study Investigators

AU - Jeng, Jiann Shing

AU - Sun, Yu

AU - Lee, Jiunn Tay

AU - Lin, Ruey Tay

AU - Chen, Chih Hung

AU - Po, Helen L.

AU - Lin, Huey Juan

AU - Liu, Chung Hsiang

AU - Sun, Ming Hui

AU - Sun, Mu Chien

AU - Chern, Chang Ming

AU - Lien, Li Ming

AU - Chiu, Hou Chang

AU - Hu, Han Hwa

AU - Chiou, Hung Yi

AU - Chen, Sien Tsong

AU - Ma, Henry

AU - Hsu, Chung Y.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Rationale: It is not uncommon for patients with ischemic stroke to have peripheral arterial disease (PAD). Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death. More effective regimens, such as dual antiplatelet agents, may be more effective for controlling progression of atherosclerosis in secondary prevention. Aim: This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack (TIA) who also have peripheral arterial disease. Design: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) study is a randomized double-blinded placebo-controlled trial. Patients with previous ischemic stroke or TIA who had been taking aspirin (100mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1·0 will be randomized into the treatment group with cilostazol (200mg/day) or the placebo group on 1:1 basis. Study outcomes: Patients will be evaluated at 1, 3, 6, 9 and 12 months after randomization. The primary endpoint is difference in change in ABI between groups. The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness (IMT) and incidence rate of major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and death; and the safety measures, including major bleeding events, hemorrhagic stroke and death of any cause. Conclusion: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents, aspirin plus cilostazol, in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD. Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD.

AB - Rationale: It is not uncommon for patients with ischemic stroke to have peripheral arterial disease (PAD). Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death. More effective regimens, such as dual antiplatelet agents, may be more effective for controlling progression of atherosclerosis in secondary prevention. Aim: This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack (TIA) who also have peripheral arterial disease. Design: The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) study is a randomized double-blinded placebo-controlled trial. Patients with previous ischemic stroke or TIA who had been taking aspirin (100mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1·0 will be randomized into the treatment group with cilostazol (200mg/day) or the placebo group on 1:1 basis. Study outcomes: Patients will be evaluated at 1, 3, 6, 9 and 12 months after randomization. The primary endpoint is difference in change in ABI between groups. The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness (IMT) and incidence rate of major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and death; and the safety measures, including major bleeding events, hemorrhagic stroke and death of any cause. Conclusion: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents, aspirin plus cilostazol, in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD. Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD.

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U2 - 10.1111/ijs.12384

DO - 10.1111/ijs.12384

M3 - Article

C2 - 25394855

AN - SCOPUS:84916238893

VL - 10

SP - 123

EP - 127

JO - International Journal of Stroke

JF - International Journal of Stroke

SN - 1747-4930

IS - 1

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