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Statin Therapy In Patients With Vasospastic Angina (STAVA)

Primary Purpose

Angina Pectoris, Variant, Statins, HMG-CoA

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris, Variant focused on measuring statin, vasospastic angina

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

20mg QD

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

all-cause death
cardiac death
cardiac arrest
myocardial infarction
angina-related hospitalization
Composite event of death or myocardial infarction
Composite event of cardiac death or myocardial infarction
statin-related complications
event rate of statin-related complications

Full Information

First Posted
May 26, 2016
Last Updated
June 14, 2017
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02790528
Brief Title
Statin Therapy In Patients With Vasospastic Angina
Acronym
STAVA
Official Title
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Funding issue
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Variant, Statins, HMG-CoA
Keywords
statin, vasospastic angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
20mg QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
20mg QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo drug will be administered.
Primary Outcome Measure Information:
Title
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization
Description
The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
all-cause death
Time Frame
3 years
Title
cardiac death
Time Frame
3 years
Title
cardiac arrest
Time Frame
3 years
Title
myocardial infarction
Time Frame
3 years
Title
angina-related hospitalization
Time Frame
3 years
Title
Composite event of death or myocardial infarction
Time Frame
3 years
Title
Composite event of cardiac death or myocardial infarction
Time Frame
3 years
Title
statin-related complications
Description
event rate of statin-related complications
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.

Learn more about this trial

Statin Therapy In Patients With Vasospastic Angina

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