A Prospective, Single-center, Randomized Study 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

Samsung Medical Center1 site in 1 country200 target enrollmentAugust 1, 2012

ConditionsVariant Angina

InterventionsSarpogrelate Atorvastatin

DrugsSarpogrelate Atorvastatin

Overview

Phase: Phase 4
Intervention: Sarpogrelate
Conditions: Variant Angina
Sponsor: Samsung Medical Center
Enrollment: 200
Locations: 1
Primary Endpoint: Ergonovine provocation test 12months later
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2012

End Date

December 31, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Hyeon-Cheol Gwon

professor

Samsung Medical Center

Eligibility Criteria

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