Contact information
Type
Scientific
Primary contact
Dr Salim Yusuf
ORCID ID
Contact details
Population Health Research Institute
McMaster University
Hamilton General Hospital
McMaster Clinic
237 Barton St E
Hamilton
Ontario L8L 2X2
Canada
+1 (0)905 527 4322 ext 44515
yusufs@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00153101
Protocol/serial number
N/A
Study information
Scientific title
Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease
Acronym
TRANSCEND
Study hypothesis
This parallel trial to ISRCTN16228603 (ONgoing Telmisartan Alone or in combination with Ramipril Global Endpoint Trial = ONTARGET) is to determine in angiotensin converting enzyme inhibitor (ACE-I) intolerant patients if telmisartan 80 mg daily is superior to placebo in reducing the composite endpoint of cardiovascular death, myocardial infacrtion (MI), stroke or hospitalisation for congestive heart failure (CHF).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Congestive heart failure
Intervention
Telmisartan (an angiotensin II blocker) or matched placebo.
Intervention type
Drug
Phase
Not Applicable
Drug names
Telmisartan
Primary outcome measures
1. Cardiovascular death
2. Non-fatal myocardial infarction
3. Non-fatal stroke
4. Hospitalisation for congestive heart failure
Secondary outcome measures
1. Newly diagnosed congestive heart failure
2. Cardiovascular revascularisation procedures
3. Newly diagnosed diabetes
4. Cognitive decline (adjudication will be done by a special committee)
5. New onset of atrial fibrillation
6. Nephropathy
Overall trial start date
01/01/2004
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults greater than or equal to 55 years
2. With a history of symptomatic coronary artery disease, cerebrovascular disease, peripheral vascular disease, or diabetes mellitus
3. Without proteinuria
4. Who are intolerant of ACE inhibitors
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
6000
Participant exclusion criteria
Does not comply with the above criteria
Recruitment start date
01/01/2004
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Korea, South, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States of America
Trial participating centre
Hamilton General Hospital
Hamilton
Ontario L8L 2X2
Canada
Sponsor information
Organisation
Boehringer Ingelheim (Canada) Ltd
Sponsor details
Research and Development
2100 Cunard Street
Laval (Québec)
H7S 2G5
Canada
+1 (0)450 682 4640
info@lav.boehringer-ingelheim.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Boehringer Ingelheim (Canada) Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00153101
Publication summary
1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15215792
2. 2005 baseline data in http://www.ncbi.nlm.nih.gov/pubmed/15868120
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17339550
4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18757085
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19770395
6. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20231536
Publication citations
-
Results
Held C, Gerstein HC, Yusuf S, Zhao F, Hilbrich L, Anderson C, Sleight P, Teo K, , Glucose levels predict hospitalization for congestive heart failure in patients at high cardiovascular risk., Circulation, 2007, 115, 11, 1371-1375, doi: 10.1161/CIRCULATIONAHA.106.661405.
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Results
, Yusuf S, Teo K, Anderson C, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P, Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial., Lancet, 2008, 372, 9644, 1174-1183, doi: 10.1016/S0140-6736(08)61242-8.
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Results
Verdecchia P, Sleight P, Mancia G, Fagard R, Trimarco B, Schmieder RE, Kim JH, Jennings G, Jansky P, Chen JH, Liu L, Gao P, Probstfield J, Teo K, Yusuf S, , Effects of telmisartan, ramipril, and their combination on left ventricular hypertrophy in individuals at high vascular risk in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease., Circulation, 2009, 120, 14, 1380-1389, doi: 10.1161/CIRCULATIONAHA.109.865774.
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Results
Böhm M, Baumhäkel M, Teo K, Sleight P, Probstfield J, Gao P, Mann JF, Diaz R, Dagenais GR, Jennings GL, Liu L, Jansky P, Yusuf S, , Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials., Circulation, 2010, 121, 12, 1439-1446, doi: 10.1161/CIRCULATIONAHA.109.864199.
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Teo K, Yusuf S, Sleight P, Anderson C, Mookadam F, Ramos B, Hilbrich L, Pogue J, Schumacher H, , Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials., Am. Heart J., 2004, 148, 1, 52-61, doi: 10.1016/j.ahj.2004.03.020.
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Sleight P, The ONTARGET/TRANSCEND Trial Programme: baseline data., Acta Diabetol, 2005, 42 Suppl 1, S50-6, doi: 10.1007/s00592-005-0181-3.