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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Variant Angina

Treatments: Drug: Sarpogrelate; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01674686

2011-12-069

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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200 participants in 2 patient groups

A

Experimental group

Description:

Sarpogrelate versus placebo

Treatment:

Drug: Sarpogrelate

B

Experimental group

Description:

Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL \> 130 mg/dl

Treatment:

Drug: Atorvastatin