STAVA: Statin Therapy In Patients With Vasospastic Angina

Sponsor

Seung-Jung Park (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02790528

Collaborator

CardioVascular Research Foundation, Korea (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris, Variant Statins, HMG-CoA	Drug: Atorvastatin Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atorvastatin 20mg QD	Drug: Atorvastatin 20mg QD
Placebo Comparator: Placebo	Drug: Placebo Placebo drug will be administered.

Arm

Intervention/Treatment

Experimental: Atorvastatin

20mg QD

Drug: Atorvastatin

20mg QD

Placebo Comparator: Placebo

Drug: Placebo

Placebo drug will be administered.

Outcome Measures

Primary Outcome Measures

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

all-cause death [3 years]
cardiac 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]
statin-related complications [3 years]
event rate of statin-related complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736

Sponsors and Collaborators

Seung-Jung Park
CardioVascular Research Foundation, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seung-Jung Park, professor of medicine, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT02790528

Other Study ID Numbers:

AMCCV2016-11

First Posted:

Jun 6, 2016

Last Update Posted:

Jun 15, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Seung-Jung Park, professor of medicine, Asan Medical Center

statin

vasospastic angina

Additional relevant MeSH terms:

Angina Pectoris

Angina Pectoris, Variant

Atorvastatin

Study Results

No Results Posted as of Jun 15, 2017