Statin Therapy In Patients With Vasospastic Angina

Angina Pectoris, Variant Clinical Trial

— STAVA  

Official title:

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02790528
• Other study ID #: AMCCV2016-11
• Status: Withdrawn
• Phase: Phase 4
• First received: May 26, 2016
• Last updated: June 14, 2017
• Start date: July 2017
• Est. completion date: December 2023

Study information

• Verified date: June 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Statins, HMG-CoA

Intervention

Drug:
• Atorvastatin
20mg QD
• Placebo
Placebo drug will be administered.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization	The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)	3 years
Secondary	all-cause death		3 years
Secondary	cardiac death		3 years
Secondary	cardiac arrest		3 years
Secondary	myocardial infarction		3 years
Secondary	angina-related hospitalization		3 years
Secondary	Composite event of death or myocardial infarction		3 years
Secondary	Composite event of cardiac death or myocardial infarction		3 years
Secondary	statin-related complications	event rate of statin-related complications	3 years