AzTrials
AzTrials

Myocardial IschemiaPhase 3NCT00007657

Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

A Phase 3 study testing Intensive medical therapy and Percutaneous Coronary Intervention (PCI) plus intensive medical therapy in people with Myocardial Ischemia, run by US Department of Veterans Affairs at 48 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Myocardial Ischemia
What is being tested?
Intensive medical therapy and Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,260 participants
Where
48 sitesin 2 countries
Study dates
Dec 1998to Jun 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in COURAGE will comprise all but very high-risk subjects, and will include those with chronic angina pectoris (Canadian Cardiovascular Society [CCS] Class I-III), uncomplicated MI, cooled down ACS, and asymptomatic (or "silent") myocardial ischemia.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

United States34 sites

  • New Mexico VA Health Care System, Albuquerque

    Albuquerque, New Mexico, 87108-5153

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48113

  • VA Maryland Health Care System, Baltimore

    Baltimore, Maryland, 21201

  • VA Medical Center, Jamaica Plain Campus

    Boston, Massachusetts, 02130

  • Jesse Brown VAMC (WestSide Division)

    Chicago, Illinois, 60612

  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106

  • Genesis Medical Center

    Davenport, Iowa, 52803-2498

  • Atlanta VA Medical and Rehab Center, Decatur

    Decatur, Georgia, 30033

  • John D. Dingell VA Medical Center, Detroit

    Detroit, Michigan, 48201

  • VA Medical Center, Durham

    Durham, North Carolina, 27705

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • Michael E. DeBakey VA Medical Center (152)

    Houston, Texas, 77030

  • VA Medical Center, Iowa City

    Iowa City, Iowa, 52246-2208

  • VA Medical Center, Kansas City MO

    Kansas City, Missouri, 64128

  • VA Medical Center, Lexington

    Lexington, Kentucky, 40502

  • Southern CA Kaiser Permanente Medical Group

    Los Angeles, California, 90027

  • MIMA Century Research Associates - Melbourne, FL

    Melbourne, Florida, 32901

  • VA Medical Center, Memphis

    Memphis, Tennessee, 38104

  • VA Medical Center

    Nashville, Tennessee, 37212-2637

  • New York Harbor HCS

    New York, New York, 10010

  • Christiana Care Health Systems-Newark, DE

    Newark, Delaware, 19718

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

    No. Little Rock, Arkansas, 72114-1706

  • VA Medical Center, Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • VA Medical Center, Philadelphia

    Philadelphia, Pennsylvania, 19104

  • VA Medical Center, Portland

    Portland, Oregon, 97201

  • Mayo Clinic Rochester - Rochester, MN

    Rochester, Minnesota, 55905

  • University of Rochester Strong Memorial Hospital

    Rochester, New York, 14642-8679

  • VA Northern California HCS

    Sacramento, California, 95655

  • VA South Texas Health Care System, San Antonio

    San Antonio, Texas, 78229

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • VA Puget Sound Health Care System, Seattle

    Seattle, Washington, 98108

  • VA Medical Center, St Louis

    St Louis, Missouri, 63106

  • VA Medical Center, Syracuse

    Syracuse, New York, 13210

  • James A. Haley Veterans Hospital, Tampa

    Tampa, Florida, 33612

Other trials in United States

Canada14 sites

  • Foothills Hospital - Calgary, Alberta - Can

    Calgary, Alberta, T2N 2T9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Sudbury Regional Hospital - Sudbury, Ontario

    Greater Sudbury, Ontario, P3E 2N8

  • Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton General Hospital - Hamilton, Ont - Can

    Hamilton, Ontario, L8L 2X2

  • London Health Sciences Ctr - London, Ont - Can

    London, Ontario, N6A 5A5

  • Trillium Health Care

    Mississauga, Ontario, L5B 2P7

  • Montreal Heart Institute - Montreal, Quebec - Can

    Montreal, Quebec, H1T 1C8

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J1C5

  • St. John Regional Hospital Facility

    Saint John, New Brunswick, E2L 4L2

  • Sunnybrook HSC - Toronto, Ontario

    Toronto, Ontario, M4N 3M5

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

    Toronto, Ontario, M5B 1W8

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • St Paul's Hospital, Vancouver - British Columbia

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

Official title: CSP #424 - Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation

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.

Read the detailed description

Primary Hypothesis: The strategy of PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI in patients with documented myocardial ischemia who meet an AHA task force Class I indication for PCI.

Secondary Hypotheses: Resource utilization and QOL comparisons and hospitalization for acute coronary syndromes will be superior in PCI plus medical therapy compared to medical therapy alone.

Primary Outcomes: All cause mortality, nonfatal MI.

Interventions: All patients will be treated with intensive medical therapy. In addition half of them will receive percutaneous coronary intervention (PCI).

Study Abstract: The COURAGE Trial is a large-scale, multicenter, randomized controlled trial comparing medical therapy and PCI plus medical therapy that is powered for "hard" clinical endpoints. Patients eligible for inclusion in COURAGE will comprise all but very high-risk subjects, and will include those with chronic angina pectoris (Canadian Cardiovascular Society [CCS] Class I-III), recent uncomplicated MI, and asymptomatic (or "silent") myocardial ischemia. Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery or PCI. We project cumulative 3-year event rates of 16.4% and 21%, respectively, which yields an absolute difference of 4.6% or relative difference of 22%. With a minimum duration of follow-up of 2 1/2 years, a maximum of 7 years, using a two-sided test of significance at the 0.05 level, and assuming a 3% crossover rate then 2% then 1% each for 2 years from meds to PCI, and annual loss to follow-up rate of 1% these event rates indicate that a sample size of 2,270 will be needed to test the hypothesis with 85% power. Fifteen VA, 19 U.S. non-VA, and 16 Canadian sites enrolled in the study. The planned study duration was 7 years, with 4 1/2 years of patient intake and 2 1/2 - 7 years of follow-up. Study operations began in January 1999 and enrollment began in June 1999. The Data and Safety Monitoring Board approved reducing the sample size to 2,270 subjects based on increasing the length of randomization and follow-up and updating the definition of MI to include biomarker positive (troponin) ACS. Enrollment is complete with 2,287 patients enrolled.

Being tested
Intensive medical therapy, Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
Keywords
PCI plus intensive medical therapy
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive medical therapyProcedure or surgery

  • Percutaneous Coronary Intervention (PCI) plus intensive medical therapyProcedure or surgery

Study groups in NCT00007657
Study groupRoleWhat they receive
1ExperimentalPercutaneous Coronary Intervention (PCI) plus intensive medical therapy
Receives: Procedure: Intensive medical therapy; Procedure: Percutaneous Coronary Intervention (PCI) plus intensive medical therapy
2Active comparatorIntensive medical therapy
Receives: Procedure: Intensive medical therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2001 (estimated)
  2. Study startDec 1998
  3. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3,260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00007657
Sponsor's protocol ID
424
Status last verified
Jun 2009
First submitted
29 Dec 2000
Last updated
15 Jun 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31023428

  • 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.

    PubMed 30773025

  • 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.

    PubMed 30384885

  • 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.

    PubMed 29752388

  • 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.

    PubMed 26559572

  • 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.

    PubMed 24440015

  • 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.

    PubMed 24016497

  • 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.

    PubMed 23973693

  • 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.

    PubMed 23838107

  • 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.

    PubMed 23538020

  • 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.

    PubMed 23500281

  • 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.

    PubMed 22877811

  • 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.

    PubMed 22045968

  • 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.

    PubMed 21718908

  • 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.

    PubMed 21304091

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intensive medical therapy and Percutaneous Coronary Intervention (PCI) plus intensive medical therapy in people with Myocardial Ischemia, run by US Department of Veterans Affairs at 48 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00007657, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in