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

Saphenous Vein Graft Disease Clinical Trial

— ACTIVE  

Official title:

Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528709
• Other study ID #: 2011.02
• Status: Completed
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: January 2017

Study information

• Verified date: September 2018
• Source: Boca Raton Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Saphenous Vein Graft Disease

Intervention

Drug:
• Atorvastatin 80 mg daily
Atorvastatin 80 mg daily for 1 year
• Atorvastatin 10 mg daily
Atorvastatin 10 mg daily for 1 year

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
United States	Lynn Heart and Vascular Institute, Boca Raton Regional Hospital	Boca Raton	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Boca Raton Regional Hospital	Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography	Vein graft stenosis 1 year after CABG based on CT coronary angiography	Within 1 year after CABG