EARly Prevention of aTHeroma Progression

NCT02105623 | Terminated Phase 4 DMC

• 1 other identifier: AMCCV2013-09
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare standard therapy (risk factor control, life style modification) versus standard therapy plus low-dose rosuvastatin therapy (5mg/day) on progression of coronary atherosclerosis in statin naive individuals who have mild CAD (nonobstructive coronary atherosclerotic plaques) and normal LDL (low-density lipoprotein) cholesterol levels(\<130mg/dl).

Conditions

Coronary Arteriosclerosis

Keywords

Coronary Arteriosclerosis; rosuvastatin

Outcome Measures

Primary Outcomes (1)

• Percent change in total atheroma volume(TAV)

  Percent change in total atheroma volume(TAV) at region of interest defined as(TAV at 24 months-TAV at baseline)/(TAV at baseline)x 100

  2 years

Secondary Outcomes (6)

• Change in PAV(Percent atheroma volume) at region of interest

  2years

• Change in overall TAV

  2years

• Change in TAV at region of interest

  2years

• Change in overall CAC(coronary artery calcification) score

  2years

• Change in number of segment of any coronary atherosclerotic plaques

  2years

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

Risk factor control Diet Exercise

Behavioral: Standard Therapy

Rosuvastatin therapy

EXPERIMENTAL

Risk factor control Rosuvastatin

Drug: Rosuvastatin

Interventions

Standard Therapy BEHAVIORAL

Risk factor control Diet Exercise for 24months

Standard Therapy

Rosuvastatin DRUG

Risk factor control rosuvastatin 5mg/day for 24months

Rosuvastatin therapy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women at least 35 years of age
• Mild CAD (nonobstructive coronary atherosclerotic plaques, lumen narrowing \<50%) and CAC score \<300 in at least one segment of proximal or mid-portion of major epicardial coronary arteries
• LDL cholesterol \<130mg/dl

You may not qualify if:

• History of stable angina, or acute coronary syndrome
• History of transient ischemic attack, or stroke
• Chronic kidney disease (eGFR\< 60ml/min)
• Diabetes mellitus with microvascular complications or insulin therapy
• Hypertriglyceridemia (triglyceride \>500mg/dl)
• Any statin therapy in the past 4 weeks
• Planned cardiac surgery or planned major non-cardiac surgery within 6 months.
• Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible).
• A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.
• Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
• Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \> 3 times upper limit of normal).
• History of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s).
• Unwillingness or inability to comply with the procedures described in this protocol.
• Positive pregnancy test (all female subjects of childbearing potential must have a urine ß-human chorionic gonadotropin(hCG) pregnancy test performed at Screening and/ or within 7 days prior to randomization) or is known to be pregnant or lactating.
• Hypersensitivity to Crestor

Sponsors & Collaborators

• CHEOL WHAN LEE, M.D., Ph.D: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Standard of Care; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 7, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)