Statin Therapy In Patients With Vasospastic Angina

NCT02790528 — Phase 4, Withdrawn, Seung-Jung Park

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT02790528, acronym STAVA
Status	Withdrawn - Funding issue
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Sponsor	Seung-Jung Park (Other); collaborators: CardioVascular Research Foundation, Korea
Conditions	Angina Pectoris, Variant, Statins, HMG-CoA
Interventions	Atorvastatin, Placebo (Drug)
Dates	start 2017-07-01 (estimated), primary completion 2023-06-01 (estimated), completion 2023-12-01 (estimated), first posted 2016-06-06, last updated 2017-06-15
Locations	1 site in South Korea

-Summary

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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Atorvastatin	Experimental	Drug: Atorvastatin	20mg QD
Placebo	Placebo comparator	Drug: Placebo

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

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Asan Medical Center	Seoul, Songpa-gu	South Korea