Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo.
Source: ClinicalTrials.gov NCT00153101 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure |
1386; 1423; 1412 | 0.8462 |
| PRIMARY 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 |
108; 119; 112 | 0.5461 |
| PRIMARY TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure |
465; 504 | 0.2192 |
| SECONDARY ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke |
1200; 1190; 1210 | 0.9086 |
| SECONDARY ONTARGET. Cardiovascular Death |
620; 598; 603 | 0.4535 |
| SECONDARY ONTARGET. Non-fatal Myocardial Infarction |
424; 431; 400 | 0.2909 |
| SECONDARY ONTARGET. Non-fatal Stroke |
364; 364; 402 | 0.2248 |
| SECONDARY ONTARGET. Hospitalization for Congestive Heart Failure |
332; 394; 354 | 0.4984 |
| SECONDARY ONTARGET. Doubling of Serum Creatinine in Diabetic Nephropathy Patients |
30; 24; 23 | 0.4221 |
| SECONDARY ONTARGET. Progression to End Stage Renal Disease (ESRD) in Diabetic Nephropathy Patients |
30; 24; 32 | 0.6248 |
| SECONDARY ONTARGET. All-cause Mortality in Diabetic Nephropathy Patients |
75; 92; 83 | 0.3682 |
| SECONDARY ONTARGET. Doubling of Serum Creatinine |
167; 160; 149 | 0.2550 |
| SECONDARY ONTARGET. Progression to ESRD |
79; 67; 71 | 0.4593 |
| SECONDARY ONTARGET. New Microalbuminuria |
763; 799; 869 | 0.0133 sig |
| SECONDARY ONTARGET. New Macroalbuminuria |
205; 229; 257 | 0.0213 sig |
| SECONDARY ONTARGET. Combined Endpoint of Doubling of Serum Creatinine, Progression to ESRD, New Microalbuminuria, or New Macroalbuminuria |
1067; 1101; 1190 | 0.0111 sig |
| SECONDARY ONTARGET. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria |
508; 483; 448 | 0.0082 sig |
| SECONDARY ONTARGET. Newly Diagnosed Congestive Heart Failure |
469; 529; 503 | 0.3732 |
| SECONDARY ONTARGET. Cardiovascular Revascularization Procedure |
1303; 1290; 1269 | 0.2713 |
| SECONDARY ONTARGET. Newly Diagnosed Diabetes |
224; 277; 249 | 0.3485 |
| SECONDARY ONTARGET. Cognitive Decline |
561; 600; 577 | 0.8690 |
| SECONDARY ONTARGET. New Onset of Atrial Fibrillation |
542; 560; 586 | 0.2666 |
| SECONDARY TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke |
384; 440 | 0.0483 sig |
| SECONDARY TRANSCEND. Cardiovascular Death |
227; 223 | 0.7764 |
| SECONDARY TRANSCEND. Non-fatal Myocardial Infarction |
114; 145 | 0.0574 |
| SECONDARY TRANSCEND. Non-fatal Stroke |
112; 136 | 0.1365 |
| SECONDARY TRANSCEND. Hospitalization for Congestive Heart Failure |
134; 129 | 0.6940 |
| SECONDARY TRANSCEND. Doubling of Serum Creatinine |
62; 40 | 0.0245 sig |
| SECONDARY TRANSCEND. Progression to ESRD |
11; 14 | 0.5798 |
| SECONDARY TRANSCEND. New Microalbuminuria |
276; 363 | 0.0006 sig |
| SECONDARY TRANSCEND. New Macroalbuminuria |
66; 101 | 0.0085 sig |
| SECONDARY TRANSCEND. Combined Endpoint of Doubling Serum Creatinine, Progression to ESRD, New Microalbuminuria or New Macroalbuminuria |
357; 448 | 0.0015 sig |
| SECONDARY TRANSCEND. Normalisation From Micro- or Macroalbuminuria to Normoalbuminuria |
135; 110 | 0.0101 sig |
| SECONDARY TRANSCEND. New Onset of Atrial Fibrillation |
181; 182 | 0.9563 |
| SECONDARY TRANSCEND. Cognitive Decline |
230; 192 | 0.0868 |
| SECONDARY TRANSCEND. Newly Diagnosed Diabetes |
124; 165 | 0.0172 sig |
| SECONDARY TRANSCEND. Cardiovascular Revascularization Procedure |
351; 390 | 0.1431 |
| SECONDARY TRANSCEND. Newly Diagnosed Congestive Heart Failure |
187; 191 | 0.8974 |
Eligibility Criteria
Inclusion Criteria
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 7 days and 160/100).
- Heart transplant recipient.
- Strokes due to subarachnoid hemorrhage
C. Other conditions:
- Significant renal disease defined as:
- Renal artery stenosis;
- Creatinine clearance 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.
Data sourced from ClinicalTrials.gov (NCT00153101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.