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The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm

Phase 4
Conditions
Variant Angina
Interventions
Registration Number
NCT01674686
Lead Sponsor
Samsung Medical Center
Brief Summary

The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
  • Angiographically proven coronary spasm; TIMI flow < 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.
Exclusion Criteria
  • Cardiac arrest by coronary spasm
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
ASarpogrelateSarpogrelate versus placebo
BAtorvastatinAtorvastatin 80mg versus no statin or simvastatin 20 mg if LDL \> 130 mg/dl
Primary Outcome Measures
NameTimeMethod
Ergonovine provocation test 12months later1 year later
Secondary Outcome Measures
NameTimeMethod
C-reactive protein lever 12months later1 year

Trial Locations

Locations (1)

Hyoen-Cheol Gwon, MD,PhD

🇰🇷

Seoul, Korea, Republic of

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