Statin Therapy In Patients With Vasospastic Angina

Phase 4

Withdrawn

• Conditions: Angina Pectoris, Variant; Statins, HMG-CoA
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT02790528
• Lead Sponsor: Seung-Jung Park

Brief Summary

The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-15
• Study Start: 2017-07
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 19 and more
• Vasospastic angina
• LDL less than 160mg/dl
• Written consent

Exclusion Criteria

• Coronary artery stenosis more than 50% or ischemic coronary disease
• History of percutaneous coronary intervention
• Cerebrovascular diseases or peripheral
• Dyslipidemia required statin therapy
• Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery
• NYHA III and IV
• Arrhythmia
• Primary cardiac electrical diseases
• Cardiac pacemaker or implantable defibrillator
• Pregnancy or breast feeding
• Life expectancy less than 2 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Atorvastatin	Atorvastatin	20mg QD

Primary Outcome Measures

Name	Time	Method
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization	3 years	The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)

Secondary Outcome Measures

Name	Time	Method
cardiac death	3 years
statin-related complications	3 years	event rate of statin-related complications
all-cause death	3 years
cardiac arrest	3 years
myocardial infarction	3 years
angina-related hospitalization	3 years
Composite event of death or myocardial infarction	3 years
Composite event of cardiac death or myocardial infarction	3 years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of