Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:14 PM
Study NCT ID:
NCT01030328
Status:
WITHDRAWN
Last Update Posted:
2024-12-18
First Post:
2009-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis
Sponsor:
Piedmont Healthcare
Organization:
Study Overview
Official Title:
Atorvastatin Plus Fenofibric Acid in the Reduction of Intermediate
Status:
WITHDRAWN
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFRICA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: