Condition category
Circulatory System
Date applied
18/12/2002
Date assigned
18/12/2002
Last edited
21/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.boehringer-ingelheim.ca/

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Sleight P, The ONTARGET/TRANSCEND Trial Programme: baseline data., Acta Diabetol, 2005, 42 Suppl 1, S50-6, doi: 10.1007/s00592-005-0181-3.

Additional files

Editorial Notes

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