- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01030328
AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis (AFRICA)
Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Comparison of the effect on the makeup of plaque will be done by using coronary artery CTA, which all participants will have at enrollment and at the end of the study.
Those who meet the eligibility criteria and sign the informed consent will be enrolled on study. Patients will be instructed on nutritional guidelines and other lifestyle changes for heart-healthy living.
If a patient has had a coronary CTA within the past two (2) months, they will not undergo the procedure at enrollment. If the patient has not had a coronary CTA within the past two (2) months, they will undergo a coronary CTA with contrast. Patients will be randomly assigned to receive either the study treatment (135 mg of TriLipix plus 40 mg of Atorvastatin) or the comparison treatment (a placebo or two pills that contains no active treatment). They will have a 50% chance of receiving the study treatment and a 50% chance of receiving the comparison treatment. This is a double-blind study, which means the patient, the research staff, and the physician will not know which treatment the patient is receiving. However, in case of an emergency, this information is immediately available to the physician.
Follow-up visits will occur at 3, 6, 12, and 18 months. All patients will have a CTA at the end of treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 10 Year Framingham risk score of ≤ 10%
- Ability and willingness to provide consent and Authorization for use of PHI
Exclusion Criteria:
- 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
- Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TriLipix + Atorvastatin
Two tables of TriLipix + Atorvastatin taken once a day by mouth.
|
135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day
|
Placebo Comparator: 2
2 sugar pills
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2 sugar pills by mouth once a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in calcified plaque volume/percent, non-calcified high-density plaque volume/percent, and low-density plaque volume/percent
Time Frame: 18, 24, 30, and 36 months after initiation
|
18, 24, 30, and 36 months after initiation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 24, 30, and 36 months after initiation
|
24, 30, and 36 months after initiation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph Miller, MD, Piedmont Heart Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH09001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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