A large, simple, randomized, double-blind, multicentre, international trial comparing the effects of Telmisartan, Ramipril, and their combination on outcomes in patients at high risk for cardiovascular events.

Condition	Treatment or Intervention	Phase
Coronary Disease Angina Pectoris Cerebrovascular Accident Myocardial Infarction	Drug: Telmisartan  Drug: Ramipril	Phase IV

Ages Eligible for Study:  55 Years and above,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

Male or female subjects, 55 years of age or older, and at high risk of developing a major CVD event are eligible if they have any of the following:

Coronary artery disease:

• Previous myocardial infarction (> 2 days post uncomplicated MI, prior to informed consent).
• Stable angina or unstable angina [(> 30 days prior to informed consent) each with documented multi-vessel coronary disease, > 50% stenosis in at least two major coronary arteries on coronary angiography, or positive stress test (ST depression > 2 mm or a positive nuclear perfusion scintigram)].
• Multi-vessel PTCA > 30 days prior to informed consent.
• Multi-vessel CABG surgery > 4 years prior to informed consent, or with recurrent angina following surgery.

Peripheral arterial disease:

• Previous limb bypass surgery or percutaneous transluminal angioplasty.
• Previous limb or foot amputation.
• History of intermittent claudication, with an ankle: arm blood pressure ratio < 0.80 on at least one side.
• Significant peripheral artery stenosis (> 50%) documented by angiography or non-invasive testing.
• Previous Stroke
• TIA > 7 days and < 1 year prior to informed consent.
• High-risk diabetics (insulin-dependent or non-insulin-dependent) with evidence of end-organ damage: retinopathy, LVH, macro or microalbuminuria, or any evidence of previous cardiac or vascular disease.

EXCLUSION CRITERIA:

Patients will be excluded if any one of the following criteria is met.

Medication use:

• Inability to discontinue ACE-inhibitors or AIIA.
• Patients with known hypersensitivity or intolerance to AIIA’s or ACE-inhibitors.

Cardiovascular disease:

• Symptomatic congestive heart failure.
• Hemodynamically significant primary valvular or outflow tract obstruction (e.g. aortic or mitral valve stenosis, asymmetric septal hypertrophy, malfunctioning prosthetic valve).
• Constrictive pericarditis.
• Complex congenital heart disease.
• Syncopal episodes of unknown etiology < 3 months before informed consent.
• Planned cardiac surgery or angioplasty within three months.
• Uncontrolled hypertension on treatment (i.e. BP > 160/100).
• Heart transplant recipient.
• Strokes due to subarachnoid hemorrhage.

Other conditions:

• Significant renal disease defined as:
• Renal artery stenosis;
• Creatinine clearance < 0.6 ml/min or serum creatinine > 265 mmol/L (> 3.0 mg/dL);
• Hyperkalemia: potassium > 5.5 mmol/L.
• Hepatic dysfunction as defined by the following laboratory parameters: SGPT (ALT) or SGOT (AST) > than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin > 20 mmol/L, biliary obstructive disorders.
• Uncorrected volume depletion or sodium depletion.
• Primary aldosteronism.
• Hereditary fructose intolerance.
• Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation.
• Patient is simultaneously taking another experimental drug.
• Patient with significant disability that precludes regular attendance at clinic for follow-up.
• Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up.
• Unable or unwilling to provide written informed consent.

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294-2041,  United States
      Athens Internal Medicine, Athens,  Alabama,  35611,  United States
Arizona
      VAMC Phoenix, Phoenix,  Arizona,  85012,  United States
      Saguaro Clinical Research, Tucson,  Arizona,  85712,  United States
      Tucson VA Medical Center, Tucson,  Arizona,  85723,  United States
      Maricopa Medical Center, Phoenix,  Arizona,  85008,  United States
Arkansas
      Garrett-Gross Clinic Ltd, Bentonville,  Arkansas,  72712,  United States
California
      University of California Davis Medical Center, Sacramento,  California,  95817,  United States
      John Muir, Mt. Diablo Health Network: East Bay Clinical Trials, Concord,  California,  94520,  United States
      Naval Medical Center San Diego, San Diego,  California,  92134,  United States
      Kaiser Permanente, Los Angeles,  California,  90027,  United States
      Schultz Clinic, San Leandro,  California,  94578,  United States
      Affiliates in Medical Specialties, Medical Groups, West Hills,  California,  91307,  United States
      Kaiser Permanente, Harbor City,  California,  90710,  United States
      Olive View Education and Research Center, Sylmar,  California,  91342,  United States
      Loma Linda VA Medical Center, Loma Linda,  California,  92354,  United States
Connecticut
      Cardiac Assoc. of Southern CT, Bridgeport,  Connecticut,  06606,  United States
      University of CT Healthcare Center, Farmington,  Connecticut,  06030-3940,  United States
District of Columbia
      Howard University Hospital, Washington,  District of Columbia,  20060,  United States
Florida
      Cleveland Clinic Florida, Weston,  Florida,  33331,  United States
      Springfield Medical Center, Panama City,  Florida,  32401,  United States
      Shands Teaching Hospital @ Univ. of Florida, Gainesville,  Florida,  32610,  United States
      Palm Harbor Medical Associates, Palm Harbor,  Florida,  34684,  United States
      Treasure Coast Infectious Disease Consultants (TCIDC), Vero Beach,  Florida,  32960,  United States
      Medical Research Institute, Tampa,  Florida,  33607,  United States
Georgia
      Kaiser Permanente of Georgia, Tucker,  Georgia,  30084,  United States
      Southern Clinical Research and Management, Inc. (Medical Village), Augusta,  Georgia,  30904,  United States
      Ellison Clinic, Conyers,  Georgia,  30094,  United States
      VAMC Augusta (509/242), Augusta,  Georgia,  30904,  United States
      St. Joseph's Candler Health System, Savannah,  Georgia,  31405,  United States
      Val-Oak Professional Corporation, Valdosta,  Georgia,  31602,  United States
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
      Primary Care Center, Sandersville,  Georgia,  31082,  United States
Idaho
      Idaho State University, Pocatello,  Idaho,  83209-8357,  United States
Illinois
      Suburban Heights Medical Center, Chicago Heights,  Illinois,  60411-1790,  United States
      Cook County Hospital General Medicine Clinic; Fantis Health Center, Chicago,  Illinois,  60612,  United States
      Cardiology-Internal Medicine Associates, S.C., Oak Lawn,  Illinois,  60453,  United States
Iowa
      Iowa Heart Center, Des Moines,  Iowa,  50314,  United States
Louisiana
      Cardiac Centers of Louisiana, LLC, Shreveport,  Louisiana,  71103-3971,  United States
      Medicine II Clinic - E.A. Conway Hospital, Monroe,  Louisiana,  71201,  United States
Maryland
      Model Clinical Research LLC, Baltimore,  Maryland,  21204,  United States
Massachusetts
      Baystate Medical Center, Springfield,  Massachusetts,  01199,  United States
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
Minnesota
      Minneapolis VAMC (111C1), Minneapolis,  Minnesota,  55417,  United States
      Berman Center for Outcomes and Clinical Research, Minneapolis,  Minnesota,  55404,  United States
      Regions Hospital Cardiology Research, St. Paul,  Minnesota,  55101,  United States
Mississippi
      Mid Delta Family Practice Clinic, Cleveland,  Mississippi,  38732,  United States
      VA Gulf Coast Veterans Health Care System, Biloxi,  Mississippi,  39531-2410,  United States
      Phillips Medical Services, Jackson,  Mississippi,  39209,  United States
Missouri
      VAMC St. Louis, St. Louis,  Missouri,  63106,  United States
      People's Health Centers, St. Louis,  Missouri,  63112,  United States
      VAMC Kansas City, Kansas City,  Missouri,  64128-2295,  United States
Nebraska
      Creighton University Cardiac Center, Omaha,  Nebraska,  68131-2044,  United States
Nevada
      VAMC Las Vegas, Las Vegas,  Nevada,  89106,  United States
New Jersey
      Cooper Hospital/UMC Department of Medicine, Camden,  New Jersey,  08103,  United States
      Westwood Cardiology Associates, Westwood,  New Jersey,  07675,  United States
      UMDNJ - New Jersey Medical School, Newark,  New Jersey,  07103,  United States
      VAMC East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Great Lakes Medical Research/Westfield Family Physicians, Westfield,  New York,  14787,  United States
      SUNY Downstate, Brooklyn,  New York,  11203,  United States
      Kaleida Health, Buffalo,  New York,  14203,  United States
      Bronx Nephrology Hypertension PC, Bronx,  New York,  10467,  United States
      VAMC Northport Medical Services (111), Northport,  New York,  11768,  United States
      VA New York Harbor Healthcare System, New York,  New York,  10010,  United States
      Cardiology & Internal Medicine, Williamsville,  New York,  14221,  United States
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Westchester Cardiology Associates, Scarsdale,  New York,  10583,  United States
      Rochester Cardiopulmonary Group, Rochester,  New York,  14621,  United States
      Mid Valley Cardiology, Kingston,  New York,  12401,  United States
      Dr. Maurer, New York,  New York,  10034,  United States
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27713,  United States
      Wake Forest University Baptist Medical Center/School of Medicine, Winston Salem,  North Carolina,  27157-1032,  United States
North Dakota
      VAMC Fargo, Fargo,  North Dakota,  68102,  United States
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
      The Lindner Research Center, Cincinnati,  Ohio,  45219,  United States
      Wright State University VA Campus, Dayton,  Ohio,  45428,  United States
      North Central Ohio Clinic, Inc., Mansfield,  Ohio,  44903,  United States
Oklahoma
      Plaza Medical Group, Oklahoma City,  Oklahoma,  73112,  United States
      University of Oklahoma College of Medicine - Tulsa, Tulsa,  Oklahoma,  74129,  United States
      Oklahoma Foundation for Cardiovascular Research, Oklahoma City,  Oklahoma,  73104,  United States
      Ringrose Clinic, Inc., Guthrie,  Oklahoma,  73044,  United States
Oregon
      Portland Cardiovascular Institute, Portland,  Oregon,  97216,  United States
Pennsylvania
      Buxmont Cardiology Associates, Sellersville,  Pennsylvania,  18960,  United States
      Cardiology Consultants of Philadelphia, Philadelphia,  Pennsylvania,  19148,  United States
      Osteopathic Internal Medicine Associates, Erie,  Pennsylvania,  16508,  United States
South Carolina
      VAMC Charleston, Charleston,  South Carolina,  29401,  United States
      University of South Carolina School of Medicine, Columbia,  South Carolina,  29203,  United States
Texas
      VA Hospital, Houston,  Texas,  77030,  United States
      Research Institute of Dallas, Dallas,  Texas,  75231,  United States
      Drummond Clinic, Dallas,  Texas,  75235,  United States
      Clinical Cardiology Research Center, Dallas,  Texas,  75246,  United States
      Frood Eelani, DO - Internal Medicine, Fort Worth,  Texas,  76104,  United States
      VAMC Houston, Houston,  Texas,  77030,  United States
      UT-Southwestern Medical Center, Dallas,  Texas,  75390-9047,  United States
      Baylor College of Medicine: Neurology Dept., Houston,  Texas,  77030,  United States
Virginia
      Clincial Research Institute of Northern VA, Springfield,  Virginia,  22151,  United States
Washington
      University of Washington, Seattle,  Washington,  98195,  United States
Wisconsin
      VAMC Milwaukee, Milwaukee,  Wisconsin,  53295,  United States
Puerto Rico
      Orocovis Medical Center, Orocovis,  00720,  Puerto Rico
      Colon-Ortiz Clinic, Caguas,  00726,  Puerto Rico
      Policlinica Familiar Monaco, Manati,  00674,  Puerto Rico
      Miguel Sosa-Padilla, MD-Private Practice, Rio Piedras,  00926,  Puerto Rico
      Centro Clinico San Patricio, Las Lomas,  00921,  Puerto Rico

Study ID Numbers:  BI 502.373
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00034931
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08