The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm
NCT ID: NCT01674686
Last Updated: 2018-02-09
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
200 participants
INTERVENTIONAL
2012-08-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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A
Sarpogrelate versus placebo
Sarpogrelate
Sarpogrelate 100mg twice a day
B
Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL \> 130 mg/dl
Atorvastatin
Atorvastatin 80mg daily
Interventions
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Sarpogrelate
Sarpogrelate 100mg twice a day
Atorvastatin
Atorvastatin 80mg daily
Eligibility Criteria
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Inclusion Criteria
* Angiographically proven coronary spasm; TIMI flow \< 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.
Exclusion Criteria
* Left main coronary spasm
* Significant fixed coronary artery stenosis; Diameter stenosis \> 70% in the major epicardial artery by coronary angiography
* Left ventricular ejection fraction \< 30%
* Coagulation disorders or bleeding tendency (Platelet count \< 50k, PT INR \> 2.0)
* Significant liver disease (AST or ALT \> 100 U/ml)
* Renal failure (S-Cr \> 2.0 mg/dl)
* hypersensitivity for statin
* Pregnancy
20 Years
70 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Hyeon-Cheol Gwon
professor
Locations
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Hyoen-Cheol Gwon, MD,PhD
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2011-12-069
Identifier Type: -
Identifier Source: org_study_id
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