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

NCT01528709

Last updated date
Study Location
Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Saphenous Vein Graft Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Redo-CABG


- Statin allergy


- Severe renal dysfunction


- Severe liver disease

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Saphenous Vein Graft DiseaseAggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)
NCT01528709
  1. Boca Raton, Florida
  2. Ottawa, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Aggressive Cholesterol Therapy to Inhibit Vein Graft Events After CABG (ACTIVE Trial)
Official Title  ICMJE Aggressive Cholesterol Therapy to Inhibit Vein Graft Events (ACTIVE Trial): Does High-Dose Postoperative Statin Therapy Improve Graft Patency After Coronary Bypass?
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Saphenous Vein Graft Disease
Intervention  ICMJE
  • Drug: Atorvastatin 80 mg daily
    Atorvastatin 80 mg daily for 1 year
  • Drug: Atorvastatin 10 mg daily
    Atorvastatin 10 mg daily for 1 year
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2016)
173
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
200
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528709
Other Study ID Numbers  ICMJE 2011.02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Dr. Alexander Kulik, Boca Raton Regional Hospital
Study Sponsor  ICMJE Boca Raton Regional Hospital
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Alexander Kulik, MD MPHLynn Heart and Vascular Institute, Boca Raton Regional Hospital
Principal Investigator:Marc Ruel, MD MPHOttawa Heart Institute Research Corporation
PRS Account Boca Raton Regional Hospital
Verification Date September 2018

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