ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31,546
- 试验地点
- 880
- 主要终点
- TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
研究概览
简要总结
The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint.
Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary Artery Disease: Previous Myocardial infarction(> 2 days prior to informed consent), or stable or previous unstable angina (> 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel Percutaneous Transluminal Coronary Angioplasty (> 30 days prior to informed consent), or previous multivessel Coronary Artery Bypass Grafting without angina (if surgery performed > 4 years prior to informed consent) or with recurrent angina after surgery.
- •Other High Risk:
- •Peripheral Arterial Disease: Previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm Blood Pressure ratio < 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing
- •Previous stroke
- •Transient ischemic Attack > 7 days and < 1 year prior to informed consent
- •Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, Left ventricular hypertrophy, micro or macro albuminuria), or any evidence of previous cardiac or vascular disease.
- •No definite and specific indication or contraindication for any of the study treatments. Written informed consent.
排除标准
- •A. Medication use:
- •Inability to discontinue Angiotension Converting Enzyme (ACE) inhibitors or Angiotension 2 receptor antagonists (AIIAs).
- •Patients with known hypersensitivity or intolerance to Angiotension 2 receptor antagonists (AIIAs) or Angiotension Converting Enzyme (ACE)inhibitors.
- •NOTE: Patients with known intolerance to Angiotension Converting Enzyme inhibitor intolerance ( ACE-I) can be enrolled in the TRANSCEND study.
- •B. 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.Blood pressure ( BP) > 160/100).
- •Heart transplant recipient.
- •Strokes due to subarachnoid hemorrhage
- •C. Other conditions:
- •Significant renal disease defined as:
- •Renal artery stenosis;
- •Creatinine clearance < 0.6 ml/min or serum creatinine > 265 umol/L (> 3.0 mg/dL);
- •Hyperkalemia: potassium > 5.5 mmol/L.
- •Proteinuria* (for TRANSCEND only).
- •Hepatic dysfunction as defined by the following laboratory parameters: Serum Glutamate Pyruvate Transaminase( SGPT) Alaninaminotransferase (ALT) or Serum Glutamic Oxaloacetic Transaminase (SGOT) Aspartate aminotransferase (AST) > than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin > 20 umol/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.
结局指标
主要结局
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
时间窗: 56 months
Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients
时间窗: 56 months
ESRD is defined by initiation of dialysis, need for renal transplantation, or eGFR \<15 mL/min/1.73 m². Diabetic nephropathy patients are diabetic patients with macro-albuminuria assessed as a Urinary Albumin Creatinine Ratio (UACR) ≥300 mg/g Crea at baseline. These renal outcomes were not adjudicated (apart from death).
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
时间窗: 56 months
The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
次要结局
- ONTARGET. New Microalbuminuria(56 months)
- ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients(56 months)
- ONTARGET. Newly Diagnosed Diabetes(56 months)
- ONTARGET. Cardiovascular Death(56 months)
- ONTARGET. Non-fatal Myocardial Infarction(56 months)
- ONTARGET. Hospitalization for Congestive Heart Failure(56 months)
- ONTARGET. Doubling of Serum Creatinine(56 months)
- ONTARGET. Newly Diagnosed Congestive Heart Failure(56 months)
- ONTARGET. Cardiovascular Revascularization Procedure(56 months)
- ONTARGET. Cognitive Decline(56 months)
- TRANSCEND. Cognitive Decline(56 months)
- TRANSCEND. Cardiovascular Revascularization Procedure(56 months)
- ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients(56 months)
- ONTARGET. Progression to ESRD(56 months)
- ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria(56 months)
- ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria(56 months)
- TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke(56 months)
- TRANSCEND. Hospitalization for Congestive Heart Failure(56 months)
- TRANSCEND. Progression to ESRD(56 months)
- TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria(56 months)
- TRANSCEND. New Onset of Atrial Fibrillation(56 months)
- TRANSCEND. Newly Diagnosed Diabetes(56 months)
- ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke(56 months)
- ONTARGET. Non-fatal Stroke(56 months)
- ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients(56 months)
- ONTARGET. New Onset of Atrial Fibrillation(56 months)
- TRANSCEND. New Microalbuminuria(56 months)
- ONTARGET. New Macroalbuminuria(56 months)
- TRANSCEND. Cardiovascular Death(56 months)
- TRANSCEND. Non-fatal Stroke(56 months)
- TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria(56 months)
- TRANSCEND. Newly Diagnosed Congestive Heart Failure(56 months)
- TRANSCEND. Non-fatal Myocardial Infarction(56 months)
- TRANSCEND. Doubling of Serum Creatinine(56 months)
- TRANSCEND. New Macroalbuminuria(56 months)