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AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis

NCT01030328 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-12-18

No results posted yet for this study

Summary

This study will examine how an approved drug (TriLipix), when used in combination with a statin (a drug that lowers blood cholesterol levels), affects the makeup of plaque. Patients will be randomly assigned to receive either the study treatment (TriLipix plus Atorvastatin) or the comparison treatment (a placebo). Comparison of the effect on the makeup of plaque will be done by using coronary artery computed tomography angiography (CTA), which all participants will have at enrollment and at the end of the study (18 months after enrollment).

Conditions

  • Coronary Atherosclerosis

Interventions

DRUG

Placebo

2 sugar pills by mouth once a day.

DRUG

TriLipix

135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day

Sponsors & Collaborators

  • Piedmont Healthcare

    lead OTHER

Principal Investigators

  • Joseph Miller, MD · Piedmont Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030328 on ClinicalTrials.gov