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

Variant Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01674686
• Other study ID #: 2011-12-069
• Status: Recruiting
• Phase: Phase 4
• First received: August 24, 2012
• Last updated: February 7, 2018
• Start date: August 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Samsung Medical Center
• Contact: Hyeon-Cheol Gwon, MD,PhD
• Phone: 82-2-3410-3419
• Email: hcgwon[@]skku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris, Variant
• Coronary Vasospasm
• Variant Angina

Intervention

Drug:
• Sarpogrelate
Sarpogrelate 100mg twice a day
• Atorvastatin
Atorvastatin 80mg daily

Locations

Country	Name	City	State
Korea, Republic of	Hyoen-Cheol Gwon, MD,PhD	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ergonovine provocation test 12months later		1 year later
Secondary	C-reactive protein lever 12months later		1 year