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

This study is currently recruiting participants.
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

February 6, 2012
December 17, 2013
March 2012
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01528709 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)
Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Saphenous Vein Graft Disease
  • Drug: Atorvastatin 80 mg daily
    Atorvastatin 80 mg daily for 1 year
  • Drug: Atorvastatin 10 mg daily
    Atorvastatin 10 mg daily for 1 year
  • Experimental: High-dose statin therapy
    Atorvastatin 80 mg daily
    Intervention: Drug: Atorvastatin 80 mg daily
  • Active Comparator: Moderate-dose statin therapy
    Atorvastatin 10 mg daily
    Intervention: Drug: Atorvastatin 10 mg daily

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Alexander Kulik, MD MPH 561-955-6300 alex_kulik@yahoo.com
United States,   Canada
 
NCT01528709
2011.02
No
Dr. Alexander Kulik, Boca Raton Regional Hospital
Boca Raton Regional Hospital
Pfizer
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
Boca Raton Regional Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP