Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2016-01-01
2020-07-31
Brief Summary
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Detailed Description
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Secondary endpoints:
1. Changes of ADP/AA/collagen-induced PFT
2. Changes of lipid profile and high sensitivity-C-reactive protein
3. Change of TEG measurements
4. Change of PWV
5. Predictors of EPC count (baseline and 1-month)
6. ischemic (CV death, MI \& stroke) and bleeding events (BARC)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CILO group
Intervention:
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.
For the CILO group, cilostazol-SR 200 mg daily was added to dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.
Drug:
Cilostazol-SR, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.
Cilostazol Tablets
Cilostazol-SR, capsule, 200mg, once daily, 30 days.
Aspirin
Astrix, capsule,100mg, once daily, 30 days.
Clopidogrel
Plavix, tablet, 75mg, once daily, 30 days.
Placebo group
Intervention:
Suspected patients with AMI were loaded with 600-mg clopidogrel and 300-mg aspirin in the emergency room.
After 3 to 5 days post-PCI (before discharge), patients were randomly allocated to the CILO group or the placebo group (1:1 fashion) based on a computer-generated randomization sequence.
In the Placebo group, placebo tablet was administered on top of dual antiplatelet therapy with aspirin (100 mg daily) and clopidogrel (75 mg daily).
Study drug is maintained for 30 days. Double blinded, Randomized, Placebo controlled Trial.
Drug:
Placebo, Tablet, 200mg, once daily. Astrix, Capsule, 100mg, once daily. Plavix, tablet, 75mg, once daily.
placebo
Placebo, tablet, 200mg, once daily, 30 days.
Aspirin
Astrix, capsule,100mg, once daily, 30 days.
Clopidogrel
Plavix, tablet, 75mg, once daily, 30 days.
Interventions
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Cilostazol Tablets
Cilostazol-SR, capsule, 200mg, once daily, 30 days.
placebo
Placebo, tablet, 200mg, once daily, 30 days.
Aspirin
Astrix, capsule,100mg, once daily, 30 days.
Clopidogrel
Plavix, tablet, 75mg, once daily, 30 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing successful coronary stent implantation
Exclusion Criteria
* a history of active bleeding or bleeding diatheses;
* contraindication to antiplatelet therapy;
* hemodynamic or electrical instability;
* oral anticoagulation therapy;
* left ventricular ejection fraction \< 30%;
* leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3;
* AST or ALT \> 3 times the respective the upper limit;
* serum creatinine level \> 3.5 mg/dL;
* stroke within 3 months;
* pregnancy;
* non-cardiac disease with a life expectancy \< 1 year;
* any patients not tolerable or suitable for coronary intervention; and
* inability to follow the protocol
20 Years
70 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Gyeongsang National University Hospital
OTHER
Responsible Party
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Yongwhi Park, MD, PhD.
Principal investigator
Principal Investigators
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Young-Hoon Jeong, MD,.PhD
Role: PRINCIPAL_INVESTIGATOR
Gyeongsang National University Changwon Hospital
References
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Park Y, Kim JH, Kim TH, Koh JS, Hwang SJ, Hwang JY, Jeong YH. Adjunctive Cilostazol to Dual Antiplatelet Therapy to Enhance Mobilization of Endothelial Progenitor Cell in Patients with Acute Myocardial Infarction: A Randomized, Placebo-Controlled EPISODE Trial. J Clin Med. 2020 Jun 1;9(6):1678. doi: 10.3390/jcm9061678.
Other Identifiers
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GNUHIRB 2012-01-005
Identifier Type: -
Identifier Source: org_study_id