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

Last updated: December 13, 2024
Sponsor: Piedmont Healthcare
Overall Status: Trial Not Available

Phase

3

Condition

Myocardial Ischemia

Coronary Artery Disease

Heart Disease

Treatment

Placebo

TriLipix

Clinical Study ID

NCT01030328
PH09001
  • Ages 18-85
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-85

  2. CAC 30-400, within 12 months of screening visit, OR intermediate stenosis oncoronary artery CTA or invasive angiography (40-69% visual estimation) without thepresence of obstructive (≥70% visual estimation) Stenosis within 3 months ofscreening 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

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 absorptionagents 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:

  7. Arrhythmia precluding diagnostic CT examination

  8. Known moderate or severe allergy to iodine-based contrast agents (mild priorreactions that could be treated as an outpatient or that could be prevented bypre-medication in the past do not constitute exclusion)

  9. Uncontrolled hypertension (SBP>180 mmHg or DBP>130 mmHg on stable treatment)

  10. Decompensated heart failure (NYHA class IV) at the time of enrollment

  11. Known Pregnancy

  12. Inability or unwillingness to consent and Authorization for use of PHI

  13. Presence of any co-morbidity that makes life expectancy less than 24 months

  14. Inability or unwillingness to comply with follow up procedures

Study Design

Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
November 01, 2009
Estimated Completion Date:
July 31, 2011

Study 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.

Connect with a study center

  • Piedmont Hospital

    Atlanta, Georgia 30309
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.