Statin Therapy In Patients With Vasospastic Angina | NCT02790528

Studies
Statin Therapy In Patients With Vasospastic Angina

NCT02790528

Sponsor

Seung-Jung Park

Status

Withdrawn

Last Update Posted

Jun 15, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Angina Pectoris, Variant
Statins, HMG-CoA

Interventions

Atorvastatin
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding issue

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

May 26, 2016

First Submission Date that Met QC Criteria

May 31, 2016

First Posted Date

Jun 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2017

Last Update Posted Date

Jun 15, 2017Actual

Name	Class
CardioVascular Research Foundation, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin	Experimental	20mg QD	Drug: Atorvastatin
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	20mg QD	Atorvastatin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
all-cause death		3 years
cardiac death		3 years
cardiac arrest

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Songpa-gu	138-736	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

This is not a publicly funded trial.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000788	Angina Pectoris, Variant

Ancestor Terms

ID	Term
D000789	Angina, Unstable
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided