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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Boca Raton Regional Hospital
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Alexander Kulik, Boca Raton Regional Hospital
ClinicalTrials.gov Identifier:
NCT01528709
First received: February 6, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528709

Contacts
Contact: Alexander Kulik, MD MPH 561-955-6300 alex_kulik@yahoo.com

Locations
United States, Florida
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital Recruiting
Boca Raton, Florida, United States, 33486
Contact: Alexander Kulik, MD MPH    561-955-6300    alex_kulik@yahoo.com   
Principal Investigator: Alexander Kulik, MD MPH         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Marc Ruel, MD MPH       mruel@ottawaheart.ca   
Principal Investigator: Marc Ruel, MD MPH         
Sponsors and Collaborators
Boca Raton Regional Hospital
Pfizer
Investigators
Principal Investigator: Alexander Kulik, MD MPH Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
Principal Investigator: Marc Ruel, MD MPH University of Ottawa Heart Institute
  More Information

Publications:
Responsible Party: Dr. Alexander Kulik, Cardiovascular Surgeon, Boca Raton Regional Hospital
ClinicalTrials.gov Identifier: NCT01528709     History of Changes
Other Study ID Numbers: 2011.02
Study First Received: February 6, 2012
Last Updated: December 17, 2013
Health Authority: United States: Western Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Canada: Ottawa Hospital Research Ethics Board

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

Additional relevant MeSH terms:
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014