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| Name | Class |
|---|---|
| National Taiwan University Hospital | OTHER |
| Shin Kong Wu Ho-Su Memorial Hospital | OTHER |
| Tri-Service General Hospital (TSGH) | OTHER |
| Far Eastern Memorial Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol | Active Comparator | Pletaal® (Cilostazol) 100 mg, bid p.o. |
|
| placebo | Placebo Comparator | Placebo 1 tablet, bid p.o. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | 100 mg, bid p.o. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint for this study is slowdown of PAD progression based on ABI. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intima-media thickness |
| 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chung Y. Hsu, MD. Ph.D. | China Medical University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| Changhua Christian Hospital | OTHER |
| Chi Mei Medical Hospital | OTHER |
| National Cheng-Kung University Hospital | OTHER |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | OTHER |
| E-DA Hospital | OTHER |
| Mackay Memorial Hospital | OTHER |
| Cathay General Hospital | OTHER |
| En Chu Kong Hospital | OTHER |
| Kuang Tien General Hospital | OTHER |
| Chung Shan Medical University | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
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| placebo | Other | 1 tablet, bid |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |