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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528709
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : August 9, 2018
Last Update Posted : September 7, 2018
Information provided by (Responsible Party):
Dr. Alexander Kulik, Boca Raton Regional Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Saphenous Vein Graft Disease Drug: Atorvastatin 80 mg daily Drug: Atorvastatin 10 mg daily Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?
Study Start Date : March 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: High-dose statin therapy
Atorvastatin 80 mg daily
Drug: Atorvastatin 80 mg daily
Atorvastatin 80 mg daily for 1 year

Active Comparator: Moderate-dose statin therapy
Atorvastatin 10 mg daily
Drug: Atorvastatin 10 mg daily
Atorvastatin 10 mg daily for 1 year

Primary Outcome Measures :
  1. Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year [ Time Frame: 1 year after CABG ]
    Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG

Secondary Outcome Measures :
  1. Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography [ Time Frame: Within 1 year after CABG ]
    Vein graft stenosis 1 year after CABG based on CT coronary angiography

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528709

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United States, Florida
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Boca Raton Regional Hospital
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Principal Investigator: Alexander Kulik, MD MPH Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
Principal Investigator: Marc Ruel, MD MPH Ottawa Heart Institute Research Corporation

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital Identifier: NCT01528709     History of Changes
Other Study ID Numbers: 2011.02
First Posted: February 8, 2012    Key Record Dates
Results First Posted: August 9, 2018
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Alexander Kulik, Boca Raton Regional Hospital:
saphenous vein graft,
graft occlusion,
Additional relevant MeSH terms:
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Behavioral Symptoms
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors