Telmisartan randomised assessment study in ACE intolerant subjects with cardiovascular disease

ISRCTN	ISRCTN75807641
DOI	https://doi.org/10.1186/ISRCTN75807641
ClinicalTrials.gov (NCT)	NCT00153101
Protocol serial number	N/A
Sponsor	Boehringer Ingelheim (Canada) Ltd
Funder	Boehringer Ingelheim (Canada) Ltd

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Salim Yusuf
Scientific

Population Health Research Institute
McMaster University
Hamilton General Hospital
McMaster Clinic
237 Barton St E
Hamilton
Ontario L8L 2X2
Canada

Phone	+1 (0)905 527 4322 ext 44515
Email	yusufs@mcmaster.ca

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease
Study acronym	TRANSCEND
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Congestive heart failure
Intervention	Telmisartan (an angiotensin II blocker) or matched placebo.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Telmisartan
Primary outcome measure(s)	1. Cardiovascular death 2. Non-fatal myocardial infarction 3. Non-fatal stroke 4. Hospitalisation for congestive heart failure
Key secondary outcome measure(s)	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
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	6000
Key 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
Key exclusion criteria	Does not comply with the above criteria
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2008

Hamilton General Hospital

Hamilton
Ontario L8L 2X2
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/03/2007		Yes	No
Results article	results	27/09/2008		Yes	No
Results article	results	06/10/2009		Yes	No
Results article	results	30/03/2010		Yes	No
Protocol article	protocol	01/07/2004		Yes	No
Basic results				No	No
Other publications	baseline data	01/04/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

21/03/2016: added link to results - basic reporting.