Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

NCT00007657 | Completed Phase 3

• 1 other identifier: 424
• Study Type: interventional
• Target: 3,260
• Locations: 2 countries
• Sites: 48

Brief Summary

PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the combined endpoint of all-cause mortality or nonfatal MI.

Conditions

Myocardial Ischemia

Keywords

PCI plus intensive medical therapy

Study Arms (2)

1

EXPERIMENTAL

Percutaneous Coronary Intervention (PCI) plus intensive medical therapy

Procedure: Intensive medical therapy; Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy

2

ACTIVE COMPARATOR

Intensive medical therapy

Procedure: Intensive medical therapy

Interventions

Intensive medical therapy PROCEDURE

1; 2

Percutaneous Coronary Intervention (PCI) plus intensive medical therapy PROCEDURE

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery or PCI.
• It is important to emphasize that as many types of CAD patients as possible--reflecting the spectrum of patients encountered in contemporary clinical practice--will be enrolled in COURAGE.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Medical Research Council of Canada: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Pfizer: collaborator
• GE Healthcare: collaborator
• Bristol-Myers Squibb: collaborator
• Astellas Pharma Inc: collaborator
• AstraZeneca: collaborator
• Sanofi: collaborator
• Datascope Corp.: collaborator
• First Horizon: collaborator
• Kos: collaborator
• Key Pharmaceuticals: collaborator
• Integrated Therapeutics Group: collaborator
• Hoest-Marion-Roussel: collaborator

Study Sites (48)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, 72114-1706, United States

Location

Southern CA Kaiser Permanente Medical Group

Los Angeles, California, 90027, United States

Location

VA Northern California HCS

Sacramento, California, 95655, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102-5037, United States

Location

Christiana Care Health Systems-Newark, DE

Newark, Delaware, 19718, United States

Location

MIMA Century Research Associates - Melbourne, FL

Melbourne, Florida, 32901, United States

Location

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Jesse Brown VAMC (WestSide Division)

Chicago, Illinois, 60612, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803-2498, United States

Location

VA Medical Center, Iowa City

Iowa City, Iowa, 52246-2208, United States

Location

VA Medical Center, Lexington

Lexington, Kentucky, 40502, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

Location

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Rochester - Rochester, MN

Rochester, Minnesota, 55905, United States

Location

VA Medical Center, Kansas City MO

Kansas City, Missouri, 64128, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, 87108-5153, United States

Location

New York Harbor HCS

New York, New York, 10010, United States

Location

University of Rochester Strong Memorial Hospital

Rochester, New York, 14642-8679, United States

Location

VA Medical Center, Syracuse

Syracuse, New York, 13210, United States

Location

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

VA Medical Center, Memphis

Memphis, Tennessee, 38104, United States

Location

VA Medical Center

Nashville, Tennessee, 37212-2637, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

VA South Texas Health Care System, San Antonio

San Antonio, Texas, 78229, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Foothills Hospital - Calgary, Alberta - Can

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

St Paul's Hospital, Vancouver - British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. John Regional Hospital Facility

Saint John, New Brunswick, E2L 4L2, Canada

Location

Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Sudbury Regional Hospital - Sudbury, Ontario

Greater Sudbury, Ontario, P3E 2N8, Canada

Location

Hamilton General Hospital - Hamilton, Ont - Can

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Ctr - London, Ont - Can

London, Ontario, N6A 5A5, Canada

Location

Trillium Health Care

Mississauga, Ontario, L5B 2P7, Canada

Location

Sunnybrook HSC - Toronto, Ontario

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael'S Hospital, Toronto, Ontario - Can

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute - Montreal, Quebec - Can

Montreal, Quebec, H1T 1C8, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

Related Publications (22)

• Mancini GBJ, Maron DJ, Hartigan PM, Spertus JA, Kostuk WJ, Berman DS, Teo KK, Weintraub WS, Boden WE; COURAGE Trial Research Group. Lifestyle, Glycosylated Hemoglobin A1c, and Survival Among Patients With Stable Ischemic Heart Disease and Diabetes. J Am Coll Cardiol. 2019 Apr 30;73(16):2049-2058. doi: 10.1016/j.jacc.2018.11.067.

  PMID: 31023428 DERIVED

• Weintraub WS, Hartigan PM, Mancini GBJ, Teo KK, Maron DJ, Spertus JA, Chaitman BR, Shaw LJ, Berman D, Boden WE. Effect of Coronary Anatomy and Myocardial Ischemia on Long-Term Survival in Patients with Stable Ischemic Heart Disease. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005079. doi: 10.1161/CIRCOUTCOMES.118.005079.

  PMID: 30773025 DERIVED

• Maron DJ, Mancini GBJ, Hartigan PM, Spertus JA, Sedlis SP, Kostuk WJ, Berman DS, Teo KK, Weintraub WS, Boden WE; COURAGE Trial Group. Healthy Behavior, Risk Factor Control, and Survival in the COURAGE Trial. J Am Coll Cardiol. 2018 Nov 6;72(19):2297-2305. doi: 10.1016/j.jacc.2018.08.2163.

  PMID: 30384885 DERIVED

• Zhang Z, Jones P, Weintraub WS, Mancini GBJ, Sedlis S, Maron DJ, Teo K, Hartigan P, Kostuk W, Berman D, Boden WE, Spertus JA. Predicting the Benefits of Percutaneous Coronary Intervention on 1-Year Angina and Quality of Life in Stable Ischemic Heart Disease: Risk Models From the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003971. doi: 10.1161/CIRCOUTCOMES.117.003971.

  PMID: 29752388 DERIVED

• Sedlis SP, Hartigan PM, Teo KK, Maron DJ, Spertus JA, Mancini GB, Kostuk W, Chaitman BR, Berman D, Lorin JD, Dada M, Weintraub WS, Boden WE; COURAGE Trial Investigators. Effect of PCI on Long-Term Survival in Patients with Stable Ischemic Heart Disease. N Engl J Med. 2015 Nov 12;373(20):1937-46. doi: 10.1056/NEJMoa1505532.

  PMID: 26559572 DERIVED

• Mancini GBJ, Hartigan PM, Shaw LJ, Berman DS, Hayes SW, Bates ER, Maron DJ, Teo K, Sedlis SP, Chaitman BR, Weintraub WS, Spertus JA, Kostuk WJ, Dada M, Booth DC, Boden WE. Predicting outcome in the COURAGE trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation): coronary anatomy versus ischemia. JACC Cardiovasc Interv. 2014 Feb;7(2):195-201. doi: 10.1016/j.jcin.2013.10.017. Epub 2014 Jan 15.

  PMID: 24440015 DERIVED

• Mancini GB, Hartigan PM, Bates ER, Chaitman BR, Sedlis SP, Maron DJ, Kostuk WJ, Spertus JA, Teo KK, Dada M, Knudtson M, Berman DS, Booth DC, Boden WE, Weintraub WS. Prognostic importance of coronary anatomy and left ventricular ejection fraction despite optimal therapy: assessment of residual risk in the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation Trial. Am Heart J. 2013 Sep;166(3):481-7. doi: 10.1016/j.ahj.2013.07.007. Epub 2013 Aug 2.

  PMID: 24016497 DERIVED

• Acharjee S, Boden WE, Hartigan PM, Teo KK, Maron DJ, Sedlis SP, Kostuk W, Spertus JA, Dada M, Chaitman BR, Mancini GB, Weintraub WS. Low levels of high-density lipoprotein cholesterol and increased risk of cardiovascular events in stable ischemic heart disease patients: A post-hoc analysis from the COURAGE Trial (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation). J Am Coll Cardiol. 2013 Nov 12;62(20):1826-33. doi: 10.1016/j.jacc.2013.07.051. Epub 2013 Aug 21.

  PMID: 23973693 DERIVED

• Spertus JA, Maron DJ, Cohen DJ, Kolm P, Hartigan P, Weintraub WS, Berman DS, Teo KK, Shaw LJ, Sedlis SP, Knudtson M, Aslan M, Dada M, Boden WE, Mancini GB; Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial Investigators and Coordinators. Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):409-18. doi: 10.1161/CIRCOUTCOMES.113.000139. Epub 2013 Jul 9.

  PMID: 23838107 DERIVED

• Maron DJ, Hartigan PM, Neff DR, Weintraub WS, Boden WE; COURAGE Trial Investigators. Impact of adding ezetimibe to statin to achieve low-density lipoprotein cholesterol goal (from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE] trial). Am J Cardiol. 2013 Jun 1;111(11):1557-62. doi: 10.1016/j.amjcard.2013.02.005. Epub 2013 Mar 25.

  PMID: 23538020 DERIVED

• Farkouh ME, Boden WE, Bittner V, Muratov V, Hartigan P, Ogdie M, Bertolet M, Mathewkutty S, Teo K, Maron DJ, Sethi SS, Domanski M, Frye RL, Fuster V. Risk factor control for coronary artery disease secondary prevention in large randomized trials. J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15. doi: 10.1016/j.jacc.2013.01.044.

  PMID: 23500281 DERIVED

• Shaw LJ, Weintraub WS, Maron DJ, Hartigan PM, Hachamovitch R, Min JK, Dada M, Mancini GB, Hayes SW, O'Rourke RA, Spertus JA, Kostuk W, Gosselin G, Chaitman BR, Knudtson M, Friedman J, Slomka P, Germano G, Bates ER, Teo KK, Boden WE, Berman DS. Baseline stress myocardial perfusion imaging results and outcomes in patients with stable ischemic heart disease randomized to optimal medical therapy with or without percutaneous coronary intervention. Am Heart J. 2012 Aug;164(2):243-50. doi: 10.1016/j.ahj.2012.05.018.

  PMID: 22877811 DERIVED

• Mancini GB, Hartigan PM, Bates ER, Sedlis SP, Maron DJ, Spertus JA, Berman DS, Kostuk WJ, Shaw LJ, Weintraub WS, Teo KK, Dada M, Chaitman BR, O'Rourke RA, Boden WE; COURAGE Investigators and Coordinators. Angiographic disease progression and residual risk of cardiovascular events while on optimal medical therapy: observations from the COURAGE Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):545-52. doi: 10.1161/CIRCINTERVENTIONS.110.960062. Epub 2011 Nov 1.

  PMID: 22045968 DERIVED

• Maron DJ, Boden WE, Spertus JA, Hartigan PM, Mancini GB, Sedlis SP, Kostuk WJ, Chaitman BR, Shaw LJ, Berman DS, Dada M, Teo KK, Weintraub WS, O'Rourke RA; COURAGE Trial Research Group. Impact of metabolic syndrome and diabetes on prognosis and outcomes with early percutaneous coronary intervention in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2011 Jul 5;58(2):131-7. doi: 10.1016/j.jacc.2011.02.046.

  PMID: 21718908 DERIVED

• Zhang Z, Kolm P, Boden WE, Hartigan PM, Maron DJ, Spertus JA, O'Rourke RA, Shaw LJ, Sedlis SP, Mancini GB, Berman DS, Dada M, Teo KK, Weintraub WS. The cost-effectiveness of percutaneous coronary intervention as a function of angina severity in patients with stable angina. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):172-82. doi: 10.1161/CIRCOUTCOMES.110.940502. Epub 2011 Feb 8.

  PMID: 21304091 DERIVED

• Chaitman BR, Hartigan PM, Booth DC, Teo KK, Mancini GB, Kostuk WJ, Spertus JA, Maron DJ, Dada M, O'Rourke RA, Weintraub WS, Berman DS, Shaw LJ, Boden WE; Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial investigators. Do major cardiovascular outcomes in patients with stable ischemic heart disease in the clinical outcomes utilizing revascularization and aggressive drug evaluation trial differ by healthcare system? Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):476-83. doi: 10.1161/CIRCOUTCOMES.109.901579. Epub 2010 Jul 27.

  PMID: 20664026 DERIVED

• Maron DJ, Boden WE, O'Rourke RA, Hartigan PM, Calfas KJ, Mancini GB, Spertus JA, Dada M, Kostuk WJ, Knudtson M, Harris CL, Sedlis SP, Zoble RG, Title LM, Gosselin G, Nawaz S, Gau GT, Blaustein AS, Bates ER, Shaw LJ, Berman DS, Chaitman BR, Weintraub WS, Teo KK; COURAGE Trial Research Group. Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2010 Mar 30;55(13):1348-58. doi: 10.1016/j.jacc.2009.10.062.

  PMID: 20338496 DERIVED

• Weintraub WS, Boden WE, Zhang Z, Kolm P, Zhang Z, Spertus JA, Hartigan P, Veledar E, Jurkovitz C, Bowen J, Maron DJ, O'Rourke R, Dada M, Teo KK, Goeree R, Barnett PG; Department of Veterans Affairs Cooperative Studies Program No. 424 (COURAGE Trial) Investigators and Study Coordinators. Cost-effectiveness of percutaneous coronary intervention in optimally treated stable coronary patients. Circ Cardiovasc Qual Outcomes. 2008 Sep;1(1):12-20. doi: 10.1161/CIRCOUTCOMES.108.798462.

  PMID: 20031783 DERIVED

• Teo KK, Sedlis SP, Boden WE, O'Rourke RA, Maron DJ, Hartigan PM, Dada M, Gupta V, Spertus JA, Kostuk WJ, Berman DS, Shaw LJ, Chaitman BR, Mancini GB, Weintraub WS; COURAGE Trial Investigators. Optimal medical therapy with or without percutaneous coronary intervention in older patients with stable coronary disease: a pre-specified subset analysis of the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation) trial. J Am Coll Cardiol. 2009 Sep 29;54(14):1303-8. doi: 10.1016/j.jacc.2009.07.013.

  PMID: 19778673 DERIVED

• Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group; Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771.

  PMID: 18703470 DERIVED

• Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.

  PMID: 18268144 DERIVED

• Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

  PMID: 17387127 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• William E. Boden

  VA South Texas Health Care System, San Antonio

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 29, 2000
• First Posted: January 4, 2001
• Study Start: December 1, 1998
• Study Completion: June 1, 2006
• Last Updated: June 15, 2009

Record last verified: 2009-06

Locations

CA (14); US (34)