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

NCT01528709 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2011.02
• Study Type: interventional
• Target: 173
• Locations: 2 countries
• Sites: 2

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.

Conditions

Saphenous Vein Graft Disease

Keywords

Statin,; CABG,; saphenous vein graft,; graft occlusion,; lipids

Outcome Measures

Primary Outcomes (1)

• Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year

  Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG

  1 year after CABG

Secondary Outcomes (1)

• Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography

  Within 1 year after CABG

Study Arms (2)

High-dose statin therapy

EXPERIMENTAL

Atorvastatin 80 mg daily

Drug: Atorvastatin 80 mg daily

Moderate-dose statin therapy

ACTIVE COMPARATOR

Atorvastatin 10 mg daily

Drug: Atorvastatin 10 mg daily

Interventions

Atorvastatin 80 mg daily DRUG

Atorvastatin 80 mg daily for 1 year

High-dose statin therapy

Atorvastatin 10 mg daily DRUG

Atorvastatin 10 mg daily for 1 year

Moderate-dose statin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing first-time CABG with at least 1 saphenous vein graft

You may not qualify if:

• Redo-CABG
• Statin allergy
• Severe renal dysfunction
• Severe liver disease

Sponsors & Collaborators

• Boca Raton Regional Hospital: lead
• Pfizer: collaborator

Study Sites (2)

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (4)

• Kulik A, Voisine P, Mathieu P, Masters RG, Mesana TG, Le May MR, Ruel M. Statin therapy and saphenous vein graft disease after coronary bypass surgery: analysis from the CASCADE randomized trial. Ann Thorac Surg. 2011 Oct;92(4):1284-90; discussion 1290-1. doi: 10.1016/j.athoracsur.2011.04.107.

  PMID: 21958773 BACKGROUND

• Kulik A, Ruel M. Lipid-lowering therapy and coronary artery bypass graft surgery: what are the benefits? Curr Opin Cardiol. 2011 Nov;26(6):508-17. doi: 10.1097/HCO.0b013e32834b9fb1.

  PMID: 21934497 BACKGROUND

• Kulik A, Ruel M. Statins and coronary artery bypass graft surgery: preoperative and postoperative efficacy and safety. Expert Opin Drug Saf. 2009 Sep;8(5):559-71. doi: 10.1517/14740330903188413.

  PMID: 19673591 BACKGROUND

• Kulik A, Abreu AM, Boronat V, Ruel M. Intensive versus moderate atorvastatin therapy and one-year graft patency after CABG: Rationale and design of the ACTIVE (Aggressive Cholesterol Therapy to Inhibit Vein Graft Events) randomized controlled trial (NCT01528709). Contemp Clin Trials. 2017 Aug;59:98-104. doi: 10.1016/j.cct.2017.06.006. Epub 2017 Jun 10.

  PMID: 28611006 DERIVED

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Alexander Kulik
• Organization: Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

alex_kulik@yahoo.com

5619556300

Study Officials

• Alexander Kulik, MD MPH

  Lynn Heart and Vascular Institute, Boca Raton Regional Hospital

  PRINCIPAL INVESTIGATOR

• Marc Ruel, MD MPH

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Surgeon

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 8, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 7, 2018
• Results First Posted: August 9, 2018

Record last verified: 2018-09

Locations

US (1); CA (1)