Coronary Atherosclerosis Clinical Trial
— AFRICAOfficial title:
Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate
Verified date | April 2014 |
Source | Piedmont Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 18 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-85 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: 1. Previous coronary revascularization (PCI, CABG) 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Piedmont Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Piedmont Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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