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

Primary Purpose

Coronary Atherosclerosis

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

TriLipix

About this trial

This is an interventional diagnostic trial for Coronary Atherosclerosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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)
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

Sites / Locations

Piedmont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TriLipix + Atorvastatin

Arm Description

Two tables of TriLipix + Atorvastatin taken once a day by mouth.

2 sugar pills

Outcomes

Primary Outcome Measures

Change in calcified plaque volume/percent, non-calcified high-density plaque volume/percent, and low-density plaque volume/percent

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.

Full Information

NCT ID

NCT01030328

First Posted

November 4, 2009

Last Updated

April 14, 2014

Sponsor

Piedmont Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT01030328

Brief Title

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

Acronym

AFRICA

Official Title

Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Lack of patient population

Study Start Date

November 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Piedmont Healthcare

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Atherosclerosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TriLipix + Atorvastatin

Arm Type

Active Comparator

Arm Description

Two tables of TriLipix + Atorvastatin taken once a day by mouth.

Arm Title

Arm Type

Placebo Comparator

Arm Description

2 sugar pills

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 sugar pills by mouth once a day.

Intervention Type

Drug

Intervention Name(s)

TriLipix

Intervention Description

135 mg of TriLipix + 40 mg of Atorvastatin by mouth once a day

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Miller, MD

Organizational Affiliation

Piedmont Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Piedmont Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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