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Statin Therapy In Patients With Vasospastic Angina

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02790528
Acronym
STAVA
Enrollment
0
Registered
2016-06-06
Start date
2017-07-31
Completion date
2023-12-31
Last updated
2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Variant, Statins, HMG-CoA

Keywords

statin, vasospastic angina

Brief summary

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

Interventions

DRUGAtorvastatin

20mg QD

DRUGPlacebo

Placebo drug will be administered.

Sponsors

CardioVascular Research Foundation, Korea
CollaboratorOTHER
Seung-Jung Park
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization3 yearsThe number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)

Secondary

MeasureTime frameDescription
cardiac death3 years
cardiac arrest3 years
myocardial infarction3 years
all-cause death3 years
Composite event of death or myocardial infarction3 years
Composite event of cardiac death or myocardial infarction3 years
statin-related complications3 yearsevent rate of statin-related complications
angina-related hospitalization3 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026