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

NCT01030328 | Withdrawn Phase 3

• 1 other identifier: PH09001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in calcified plaque volume/percent, non-calcified high-density plaque volume/percent, and low-density plaque volume/percent

  18, 24, 30, and 36 months after initiation

Secondary Outcomes (1)

• The secondary endpoint of the study will be the change in PAV of the "Study Lesion" from baseline to follow-up. PAV will be expressed as a ratio of the plaque volume/total vessel volume.

  24, 30, and 36 months after initiation

Study Arms (2)

TriLipix + Atorvastatin

ACTIVE COMPARATOR

Two tables of TriLipix + Atorvastatin taken once a day by mouth.

Drug: TriLipix

2

PLACEBO COMPARATOR

2 sugar pills

Drug: Placebo

Interventions

Placebo DRUG

2 sugar pills by mouth once a day.

2

TriLipix DRUG

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

TriLipix + Atorvastatin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• CAC 30-400, within 12 months of screening visit, OR intermediate stenosis on coronary artery CTA or invasive angiography (40-69% visual estimation) without the presence of obstructive (≥70% visual estimation) Stenosis within 3 months of screening visit
• LDL-C ≥ 100 mg/dL and LDL-C ≤190 mg/dL at screening or baseline visit
• TG\>150 mg/dL and TG/HDL\>3.5 at screening or baseline visit
• Year Framingham risk score of ≤ 10%
• Ability and willingness to provide consent and Authorization for use of PHI

You may not qualify if:

• Previous coronary revascularization (PCI, CABG)
• Current lipid lowering therapy (includes statins, fibrates, niacin, omega 3 agents, intestinal cholesterol absorption inhibitors, cholestatic cholesterol absorption agents and other anti-lipemic agents.)
• Known genetic form of hypercholesterolemia (e.g. familial hypercholesterolemia, etc.)
• Creatinine 1.5 mg/dL or greater at baseline visit
• Fasting serum triglycerides 500 mg/dL or greater at screening or baseline visit
• Inability to perform CTA:
• Arrhythmia precluding diagnostic CT examination
• Uncontrolled hypertension (SBP\>180 mmHg or DBP\>130 mmHg on stable treatment)
• Decompensated heart failure (NYHA class IV) at the time of enrollment
• Known Pregnancy
• Inability or unwillingness to consent and Authorization for use of PHI
• Presence of any co-morbidity that makes life expectancy less than 24 months
• Inability or unwillingness to comply with follow up procedures

Sponsors & Collaborators

• Piedmont Healthcare: lead

Study Sites (1)

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Joseph Miller, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: December 11, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 18, 2024

Record last verified: 2024-11

Locations

US (1)