CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 173 enrolled
Drug / intervention
Atorvastatin 80 mg daily +1 moredrug
Likely dose
Atorvastatin 80 mg dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01528709
NCT01528709Phase 3Completed

Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?

Boca Raton Regional Hospital·interventional·Posted Feb 8, 2012·Updated Sep 7, 2018

In Brief

A Phase 3 clinical trial evaluating Atorvastatin 80 mg daily and Atorvastatin 10 mg daily for Saphenous Vein Graft Disease. Completed, enrolled 173 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2012
Enrollment StartMar 1, 2012
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.4 years ago

Interventions

Atorvastatin 80 mg dailydrug

Atorvastatin 80 mg daily for 1 year

Atorvastatin 10 mg dailydrug

Atorvastatin 10 mg daily for 1 year