AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis
NCT ID: NCT01030328
Last Updated: 2024-12-18
Study Results
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2009-11-30
2011-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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TriLipix + Atorvastatin
Two tables of TriLipix + Atorvastatin taken once a day by mouth.
TriLipix
135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day
2
2 sugar pills
Placebo
2 sugar pills by mouth once a day.
Interventions
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Placebo
2 sugar pills by mouth once a day.
TriLipix
135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day
Eligibility Criteria
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Inclusion Criteria
2. 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
3. LDL-C ≥ 100 mg/dL and LDL-C ≤190 mg/dL at screening or baseline visit
4. TG\>150 mg/dL and TG/HDL\>3.5 at screening or baseline visit
5. 10 Year Framingham risk score of ≤ 10%
6. Ability and willingness to provide consent and Authorization for use of PHI
Exclusion Criteria
2. Current lipid lowering therapy (includes statins, fibrates, niacin, omega 3 agents, intestinal cholesterol absorption inhibitors, cholestatic cholesterol absorption agents and other anti-lipemic agents.)
3. Known genetic form of hypercholesterolemia (e.g. familial hypercholesterolemia, etc.)
4. Creatinine 1.5 mg/dL or greater at baseline visit
5. Fasting serum triglycerides 500 mg/dL or greater at screening or baseline visit
6. Inability to perform CTA:
1. Arrhythmia precluding diagnostic CT examination
2. 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)
7. Uncontrolled hypertension (SBP\>180 mmHg or DBP\>130 mmHg on stable treatment)
8. Decompensated heart failure (NYHA class IV) at the time of enrollment
9. Known Pregnancy
10. Inability or unwillingness to consent and Authorization for use of PHI
11. Presence of any co-morbidity that makes life expectancy less than 24 months
12. Inability or unwillingness to comply with follow up procedures
18 Years
85 Years
ALL
No
Sponsors
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Piedmont Healthcare
OTHER
Responsible Party
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Principal Investigators
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Joseph Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Locations
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Piedmont Hospital
Atlanta, Georgia, United States
Countries
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Other Identifiers
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PH09001
Identifier Type: -
Identifier Source: org_study_id