EARly Prevention of aTHeroma Progression (EARTH)

C

CHEOL WHAN LEE, M.D., Ph.D

Status and phase

Terminated
Phase 4

Conditions

Coronary Arteriosclerosis

Treatments

Drug: Rosuvastatin
Behavioral: Standard Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02105623
AMCCV2013-09

Details and patient eligibility

About

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).

Enrollment

111 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Skeletal muscle disease
  • Combination use with cyclosporine
  • Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
  • Combination use of protease inhibitor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

111 participants in 2 patient groups

Standard Therapy
Active Comparator group
Description:
Risk factor control Diet Exercise
Treatment:
Behavioral: Standard Therapy
Rosuvastatin therapy
Experimental group
Description:
Risk factor control Rosuvastatin
Treatment:
Drug: Rosuvastatin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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