Eliminate Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-09-30

Brief Summary

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The purpose of this study is to determine whether pharmacologic lowering of low density lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate or markedly reduce the composite endpoint of incident all cause mortality, myocardial infarction, stroke or coronary revascularization.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atorvastatin

Atorvastatin(Lipitor) in addition to the usual guideline based care

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

20 mg of atorvastatin daily

Guideline based care

Current guidelines for lipid-management in healthy middle aged men and women only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Atorvastatin

20 mg of atorvastatin daily

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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Inclusion Criteria

* Men 35-50 years of age
* Women 45 - 59 years of age (must be sterile or \>2 years postmenopausal)
* LDL cholesterol greater than 1.8 mmol/L (70 mg/dL) based on testing performed within 1 year
* One risk factor for Coronary Heart Disease other than lipid abnormality:
* Obesity and hypertension \[BP \>140 mmHg systolic and waist circumference \> 100 cm in men and \>90 cm in women\]
* family history of premature myocardial infarction \[\<60 years\]
* South Asian ethnic history
* currently smoking

Exclusion Criteria

* Currently taking cholesterol lowering medication
* Qualify for cholesterol lowering medication based on current guidelines
* Significant renal dysfunction (creatinine clearance \<30 ml/min)
* Significant hepatic dysfunction (AST/ALT \>2.0 times upper limit of normal)
* Active malignancy
* Diabetes
* Progressive or terminal illness, or other condition in which subject is unlikely to survive the study period
* Known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin
* Participation in a clinical trial (except observational studies) within previous 30 days
* Received any investigation product within 30 days prior to participation in this clinical trial
* Previously enrolled in this clinical trial

Minimum Eligible Age

35 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes