Statin Therapy In Patients With Vasospastic Angina

NCT02790528 | Withdrawn Phase 4 DMC

• 1 other identifier: AMCCV2016-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Angina Pectoris, Variant; Statins, HMG-CoA

Keywords

statin; vasospastic angina

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• all-cause death

  3 years

• cardiac death

  3 years

• cardiac arrest

  3 years

• myocardial infarction

  3 years

• angina-related hospitalization

  3 years

Study Arms (2)

Atorvastatin

EXPERIMENTAL

20mg QD

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Atorvastatin DRUG

20mg QD

Atorvastatin

Placebo DRUG

Placebo drug will be administered.

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 and more
• Vasospastic angina
• LDL less than 160mg/dl
• Written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 6, 2016
• Study Start: July 1, 2017
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)