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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose statin therapy | Experimental | Atorvastatin 80 mg daily |
|
| Moderate-dose statin therapy | Active Comparator | Atorvastatin 10 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 80 mg daily | Drug | Atorvastatin 80 mg daily for 1 year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynn Heart and Vascular Institute, Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21958773 | Background | 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. | |
| 21934497 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose Statin Therapy | Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year |
| FG001 | Moderate-dose Statin Therapy | Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose Statin Therapy | Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year |
| BG001 | Moderate-dose Statin Therapy | Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Units | Vein grafts | 1 year after CABG | Vein grafts | Vein grafts |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-dose Statin Therapy | Atorvastatin 80 mg daily Atorvastatin 80 mg daily: Atorvastatin 80 mg daily for 1 year |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uncontrolled lipid levels | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander Kulik | Lynn Heart and Vascular Institute, Boca Raton Regional Hospital | 5619556300 | alex_kulik@yahoo.com |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin 10 mg daily |
| Drug |
Atorvastatin 10 mg daily for 1 year |
|
| University of Ottawa Heart Institute |
| Ottawa |
| Ontario |
| K1Y 4W7 |
| Canada |
| 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. |
| 19673591 | 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. |
| 28611006 | Derived | 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. |
| allergy |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Vein grafts |
|
|
| 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 | Posted | Count of Units | Vein grafts | Within 1 year after CABG | Vein grafts | Vein grafts |
|
|
|
| 2 |
| 86 |
| 5 |
| 86 |
| 0 |
| 86 |
| EG001 | Moderate-dose Statin Therapy | Atorvastatin 10 mg daily Atorvastatin 10 mg daily: Atorvastatin 10 mg daily for 1 year | 0 | 87 | 7 | 87 | 0 | 87 |
| Elevated CK levels | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Elevated liver enzymes | Hepatobiliary disorders | Systematic Assessment |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |