Overview

This trial is active, not recruiting.

Condition saphenous vein graft disease
Treatments atorvastatin 80 mg daily, atorvastatin 10 mg daily
Phase phase 3
Sponsor Boca Raton Regional Hospital
Collaborator Pfizer
Start date March 2012
End date December 2016
Trial size 173 participants
Trial identifier NCT01528709, 2011.02

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Atorvastatin 80 mg daily
atorvastatin 80 mg daily
Atorvastatin 80 mg daily for 1 year
(Active Comparator)
Atorvastatin 10 mg daily
atorvastatin 10 mg daily
Atorvastatin 10 mg daily for 1 year

Primary Outcomes

Measure
Saphenous vein graft patency
time frame: 1 year after CABG

Secondary Outcomes

Measure
Safety of high-dose statin therapy early after CABG
time frame: Within 1 year after CABG

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients undergoing first-time CABG with at least 1 saphenous vein graft Exclusion Criteria: - Redo-CABG - Statin allergy - Severe renal dysfunction - Severe liver disease

Additional Information

Official title Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?
Principal investigator Alexander Kulik, MD MPH
Description The current clinical guidelines recommend treatment to achieve LDL levels <100 mg/dL after surgical coronary revascularization. However, recent studies have illustrated that even more intensive lipid reduction with high-dose statins can further improve cardiovascular outcomes. Targeting LDL levels to 70 mg/dL after CABG with intensive statin therapy may prevent the process of postoperative saphenous vein graft disease and lead to improved graft patency. Therefore, in the ACTIVE Trial, we will conduct a randomized controlled trial comparing high-dose (80 mg atorvastatin) to moderate-dose (10 mg atorvastatin)statin therapy in patients undergoing CABG with saphenous vein grafts. The effect of aggressive cholesterol therapy on the process of vein graft disease will be examined with computed tomography (CT) coronary angiography one year after CABG. This study will address the subject of postoperative high-dose statin therapy and help determine the optimal lipid-lowering strategy following CABG.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Boca Raton Regional Hospital.