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

NCT01528709 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2018-09-07

Study results available
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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.

Conditions

  • Saphenous Vein Graft Disease

Interventions

DRUG

Atorvastatin 80 mg daily

Atorvastatin 80 mg daily for 1 year

DRUG

Atorvastatin 10 mg daily

Atorvastatin 10 mg daily for 1 year

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Boca Raton Regional Hospital

    lead OTHER

Principal Investigators

  • Alexander Kulik, MD MPH · Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

  • Marc Ruel, MD MPH · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-01-31
Completion
2017-01-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528709 on ClinicalTrials.gov