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

This study has been terminated.
(Lack of patient population)
Sponsor:
Information provided by:
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT01030328
First received: November 4, 2009
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention Phase
Coronary Atherosclerosis
Drug: Placebo
Drug: TriLipix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TriLipix + Atorvastatin
Two tables of TriLipix + Atorvastatin taken once a day by mouth.
Drug: TriLipix
135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day
Placebo Comparator: 2
2 sugar pills
Drug: Placebo
2 sugar pills by mouth once a day.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030328

Locations
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Investigators
Principal Investigator: Joseph Miller, MD Piedmont Heart Institute
  More Information

No publications provided

Responsible Party: Joseph Miller, MD, Piedmont Hosptial
ClinicalTrials.gov Identifier: NCT01030328     History of Changes
Other Study ID Numbers: PH09001
Study First Received: November 4, 2009
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Atorvastatin
Fenofibric acid
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014