ISRCTN ISRCTN74843649
DOI https://doi.org/10.1186/ISRCTN74843649
Secondary identifying numbers N/A
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
20/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nigel Stephens
Scientific

Cardiology Department
Northwick Park Hospital
Harrow
Middlesex
HA1 3UJ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleRandomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS)
Study acronymCHAOS
Study objectivesThe hypothesis tested was: treatment with a high dose of alpha-tocopherol would reduce subsequent risk of myocardial infarction (MI) and cardiovascular death in patients with established ischaemic heart disease
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular diseases: Heart disease
InterventionAlpha-tocopherol 800 IU daily for first 546 patients, alpha-tocopherol 400 IU daily for remainder versus placebo
Intervention typeOther
Primary outcome measureCardiovascular death and non-fatal MI as well as non-fatal MI alone
Secondary outcome measuresNot provided at time of registration
Overall study start date10/10/1992
Completion date18/06/1995

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsAdded December 2008
Key inclusion criteriaPatients with angiographically proven coronary atherosclerosis
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/10/1992
Date of final enrolment18/06/1995

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Cardiology Department
Middlesex
HA1 3UJ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Eastern (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/03/1996 Yes No
Results article results 30/01/1999 Yes No