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Phase 3 N=173 Randomized Quadruple-blind Prevention

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

Saphenous Vein Graft Disease

Enrolled (actual)
173
Serious AEs
6.9%
Results posted
Aug 2018
Primary outcome: Primary: Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year — 14; 16 Vein grafts

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Atorvastatin 80 mg daily (Drug); Atorvastatin 10 mg daily (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boca Raton Regional Hospital
Primary completion
Jan 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year
14; 16
SECONDARY
Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography
4; 7

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01528709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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