Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)

Completed · Phase 3

Conditions studied: Saphenous Vein Graft Disease

In brief

During coronary artery bypass graft surgery (CABG), saphenous vein from the leg is used to bypass the atherosclerotic blockages in the arteries of the heart. Unfortunately, vein bypasses themselves develop blockages over time, a process termed saphenous vein graft disease. By lowering cholesterol levels in the blood, statin medications are used after surgery to prevent the development of atherosclerotic blockages in the vein bypasses. Recently, higher doses of statin medications have been introduced, with some studies showing that they are more effective than traditional doses when used in heart attack patients. Furthermore, laboratory tests have shown that higher doses of statin medications can slow the development of atherosclerosis. Despite these benefits, very little is known regarding the use of high-dose statin therapy after bypass surgery in humans. The goal of this study will be to see if high-dose statin therapy will prevent the development of vein graft occlusion during the first year after bypass surgery. Patients will be randomized to receive either high-dose statin therapy or conventional moderate-dose statin therapy starting within 4 days of surgery and continuing for the duration of one year after the operation. The statin medication will be given in capsule form. During the course of this study, neither the patient nor the health care team will know which treatment each patient is receiving. One year after bypass surgery, a computed tomography (CT) coronary angiogram will be performed to evaluate the patency of the vein bypasses.

Key facts

Study ID

NCT01528709

Run by

Boca Raton Regional Hospital

People needed

173

Starts

2012-03-01

Expected to finish

2017-01-01

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing first-time CABG with at least 1 saphenous vein graft

You may not qualify if…

• Redo-CABG
• Statin allergy
• Severe renal dysfunction
• Severe liver disease

Where it is running

• Lynn Heart and Vascular Institute, Boca Raton Regional Hospital — Boca Raton, Florida, United States
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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