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PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI Clinical research trials and PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI. PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI clinical trial. Test subjects typically obtain the finest healthcare available for their PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.

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PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI



PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI

For Condition: Myocardial Ischemia
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Pfizer,Merck,Medical Research Council of Canada,Dupont Pharmaceuticals
Synopsis: 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.
Details: Primary Hypothesis: The strategy of PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality, nonfatal MI or biomarker positive (troponin) ACS 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 unstable angina will be superior in PTCA plus medical therapy compared to medical therapy alone. Primary Outcomes: All cause mortality, nonfatal MI, or biomarker (Troponin) positive ACS Interventions: All patients will be treated with intensive medical therapy. In addition half of them will receive a percutaneous intervention. 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), 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. It is important to emphasize that as many types of CHD patients as possible--reflecting the spectrum of patients encountered in contemporary clinical practice--will be enrolled in COURAGE. The primary hypothesis for the study is that PCI (optimal catheter-based coronary revascularization) + intensive medical therapy is superior to intensive medical therapy alone using the above primary endpoint. We project cumulative 3-year event rates of 15% and 19%, respectively, which yields an absolute difference of 4% or relative difference of 21%. Assuming a minimum duration of follow-up of 1 1/2 years and using a two-sided test of significance at the 0.05 level, 3% crossover rate then 2% then 1% each for 2 years from meds to PCI, these rates indicate that a sample size of 3,050 will be needed to test the hypothesis with 80% power and annual loss to follow-up rate of 1%. To allow for sequential monitoring 3,120 patients must be enrolled in order to obtain the required number of endpoints. It is anticipated that enrolling sites (12 V.A., 12 U.S. non-V.A., 12 Canadian) will be needed to accrue 3,120 patients. The planned study duration is 6 years, with 4.5 years of patient intake and 1.5 years of follow-up. The study was kicked off in January 1999 and enrollment began in July 1999; 1487 patients have been enrolled by December 28, 2001. The DSMB recommended reducing the sample size from 3260 subjects to 3120 subjects.
Eligibility:
Study Type:
  Interventional, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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, and asymptomatic (or "silent") myocardial ischemia. Patients may have single- or multi-vessel coronary artery disease and may have had prior bypass graft surgery. It is important to emphasize that as many types of CHD patients as possible--reflecting the spectrum of patients encountered in contemporary clinical practice--will be enrolled in COURAGE.
Total Enrollment: 3260

Location and Contact Information:

St. John Regional Hospital Facility *Recruiting*
St. John,  New Brunswick,  E2L 4L2
Canada
Recruiting David  Marr 506-633-0479

Queen Elizabeth Ii Hsc, Halifax, Nova Scotia - Can *Recruiting*
Halifax,  Nova Scotia,  B3H 3A7
Canada
Recruiting Lawrence  Title 902-473-8470

University of Oklahoma HSC *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Saihari  Sadanandan 405-271-2856

Southern CA Kaiser Permanente Medical Group *Recruiting*
Los Angeles,  California,  90027
United States
Recruiting Peter  Mahrer 323-783-4064

St. Michael's Hospital, Toronto, Ontario - Can *Recruiting*
Toronto,  Ontario,  M5B 1W8
Canada
Recruiting Bradley  Strauss 416-864-5913

Hartford Hospital *Recruiting*
Hartford,  Connecticut,  06102-5037
United States
Recruiting Francis  Kiernan 860-545-2975

Montreal Heart Institute - Montreal, Quebec - Can *Recruiting*
Montreal,  Quebec,  H1T 1C8
Canada
Recruiting Gilbert  Gosselin 514-376-3330

James A. Haley Veterans Hospital *Recruiting*
Tampa,  Florida,  33612
United States
Recruiting Robert  Zoble 813-972-7618

VAMC - Albuquerque, NM *Recruiting*
Albuquerque,  New Mexico,  87108
United States
Recruiting Kathleen  Allen 505-256-4502

Hopital du Sacre-Coeur de Montreal *Recruiting*
Montreal,  Quebec,  H4J1C5
Canada
Recruiting Donald  Palisaitis 514-338-2340

St Paul's Hospital, Vancouver - British Columbia *Recruiting*
Vancouver,  British Columbia,  V6Z 1Y6
Canada
Recruiting Ronald  Carere 604-681-6074

University of Maryland Medical Systems *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Mike  Miller 410-328-6299

London Health Sciences Ctr - London, Ontario - Can *Recruiting*
London,  Ontario,  N6A 5A5
Canada
Recruiting Willliam  Kostuk 519-663-3263

VAMC - Iowa City, IA *Recruiting*
Iowa City,  Iowa,  52246
United States
Recruiting James  Rossen 319-356-3413

Cleveland Clinic - Cleveland, OH *No longer recruiting*
Cleveland,  Ohio,  44195-5066
United States
No longer recruiting  

University of California, Davis, Ca *Terminated*
Sacramento,  California,  95817
United States
Terminated  

Audie Murphy VAMC - San Antonio, TX *Recruiting*
San Antonio,  Texas,  78284
United States
Recruiting Robert  O'Rourke 210-617-5100

MIMA Century Research Associates - Melbourne, FL *Recruiting*
Melbourne,  Florida,  32901
United States
Recruiting Ralph  Vicari 321-725-4500

Barnes-Jewish Hospital of St Louis - St Louis, MO *No longer recruiting*
St. Louis,  Missouri,  63110-1093
United States
No longer recruiting  

Atlanta Vamc - Decatur, Ga *Recruiting*
Decatur,  Georgia,  30033
United States
Recruiting Mark  Leimbach 404-321-6111

University of Michigan Medical Center - Ann Arbor, *Recruiting*
Ann Arbor,  Michigan,  48109-0022
United States
Recruiting Eric  Bates 734-936-5840

Mayo Clinic Rochester - Rochester, MN *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Peter  Berger 507-255-4152

Sunnybrook HSC - Toronto, Ontario *Recruiting*
Toronto,  Ontario,  M4N 3M5
Canada
Recruiting Eric  Cohen 416-480-5880

Suny Health Science Center and Syracuse, NY *No longer recruiting*
Syracuse,  New York,  13210
United States
No longer recruiting  

University of Rochester Strong Memorial Hospital *Recruiting*
Rochester,  New York,  14642-8679
United States
Recruiting Ronald  Schwartz 716-275-0026

Hospital of the University of PA - Philadelphia *Terminated*
Philadelphia,  Pennsylvania,  19104
United States
Terminated  

Trillium Health Care *Recruiting*
Mississauga,  Ontario,  L5B 2P7
Canada
Recruiting Charles  Lazzam 905-615-0012

Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Michael  Davidson 312-563-2011

VAMC - Lexington, KY *Recruiting*
Lexington,  Kentucky,  40511
United States
Recruiting David  Booth 859-281-4955

VAMC - Portland *Recruiting*
Portland,  Oregon,  97201
United States
Recruiting Edward  Murphy 503-220-8262

VAMC - New York. NY *Recruiting*
New York City,  New York,  10010
United States
Recruiting Steven  Sedlis 212-951-3335

Vancouver Hospital and HSC - Vancouver, British Co *Recruiting*
Vancouver,  British Columbia,  V5Z 1L8
Canada
Recruiting Christopher  Buller 604-875-5324

Sudbury Regional Hospital - Sudbury, Ontario *Recruiting*
Sudbury,  Ontario,  P3E 6B4
Canada
Recruiting Shah  Nawaz 705-522-2682

Foothills Hospital - Calgary, Alberta - Can *Recruiting*
Calgary,  Alberta,  T2N 2T9
Canada
Recruiting Merril  Knudtson 604-875-4107

Emory University Hospital - Atlanta, GA *No longer recruiting*
Atlanta,  Georgia,  30322
United States
No longer recruiting  

University of Alberta Hospital - Edmonton, Alberta *Recruiting*
Edmonton,  Alberta,  T6G 2B7
Canada
Recruiting Wayne  Tymchak 780-407-1889

Mid-America Heart Institute - Kansas City, MO *Recruiting*
Kansas City,  Missouri,  64111-3267
United States
Recruiting James  O'Keefe 816-931-1883

VAMC - Durham, NC *Recruiting*
Durham,  North Carolina,  27705
United States
Recruiting Kenneth  Morris 919-286-6942

VAMC - Houston, TX *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Alvin  Blaustein 713-794-7758

Boston Medical Center - Boston, MA *Recruiting*
Boston,  Massachusetts,  02118-2315
United States
Recruiting Alice  Jacobs 617-638-8707

VAMC - Little Rock, AR *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Jorge  Saucedo 501-257-5795

VAMC - Seattle, WA *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting Kenneth  Lehmann 206-764-2512

Hamilton General Hospital - Hamilton, Ont - Can *Recruiting*
Hamilton,  Ontario,  L8L 2X2
Canada
Recruiting Madhu  Natarajan 905-527-6241

Christiana Care Health Systems-Newark, DE *No longer recruiting*
Newark,  Delaware,  19718
United States
No longer recruiting  

University Health Network *Recruiting*
Toronto,  Ontario,  M5G 2C4
Canada
Recruiting Vlad  Dzavik 416-340-5986


Additional Information:
Study ID Numbers:
  424; 
Study Start Date: June 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007657

Other Myocardial Ischemia Studies:
1. PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI

2. Cardiovascular Disease Mortality in The NAS-NRC Twin Registry

3. Quality of Life in Patients with Chronic Ischemic Heart Disease

4. Harvard Atherosclerosis Reversibility Project (HARP)

5. Coronary Drug Project

Related Studies:

Other Myocardial Ischemia Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials

PCI plus intensive medical therapy will be superior to intensive medical therapy alone in reducing all cause mortality or nonfatal MI

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