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

This study has been completed.
Information provided by (Responsible Party):
Dr. Alexander Kulik, Boca Raton Regional Hospital Identifier:
First received: February 6, 2012
Last updated: January 31, 2017
Last verified: January 2017

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 Intervention Phase
Saphenous Vein Graft Disease
Drug: Atorvastatin 80 mg daily
Drug: Atorvastatin 10 mg daily
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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?

Resource links provided by NLM:

Further study details as provided by Boca Raton Regional Hospital:

Primary Outcome Measures:
  • Saphenous vein graft patency [ 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:
  • Safety of high-dose statin therapy early after CABG [ Time Frame: Within 1 year after CABG ]
    Safety measures will include the incidence of major adverse cardiovascular events (mortality, myocardial infarction, cerebrovascular accident, hospitalization for coronary ischemia, and need for coronary intervention), the incidence of elevations in liver enzyme levels, the incidence of myopathy, and the incidence of rhabdomyolysis.

Enrollment: 173
Study Start Date: March 2012
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01528709

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
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
  More Information

Responsible Party: Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital Identifier: NCT01528709     History of Changes
Other Study ID Numbers: 2011.02
Study First Received: February 6, 2012
Last Updated: January 31, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boca Raton Regional Hospital:
saphenous vein graft,
graft occlusion,

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on April 21, 2017