Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
20/10/2010
Prospective/Retrospective
Retrospectively 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 Nigel Stephens

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS)

Acronym

CHAOS

Study hypothesis

The 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular diseases: Heart disease

Intervention

Alpha-tocopherol 800 IU daily for first 546 patients, alpha-tocopherol 400 IU daily for remainder versus placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cardiovascular death and non-fatal MI as well as non-fatal MI alone

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/10/1992

Overall trial end date

18/06/1995

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with angiographically proven coronary atherosclerosis

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added December 2008

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/10/1992

Recruitment end date

18/06/1995

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiology Department
Middlesex
HA1 3UJ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Eastern (UK)

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

Publication summary

1996 results on http://www.ncbi.nlm.nih.gov/pubmed/8622332
1999 results on http://www.ncbi.nlm.nih.gov/pubmed/9950454

Publication citations

  1. Results

    Stephens NG, Parsons A, Schofield PM, Kelly F, Cheeseman K, Mitchinson MJ, Randomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS), Lancet, 1996, 347, 9004, 781-786.

  2. Results

    Mitchinson MJ, Stephens NG, Parsons A, Bligh E, Schofield PM, Brown MJ, Mortality in the CHAOS trial., Lancet, 1999, 353, 9150, 381-382, doi: 10.1016/S0140-6736(05)74955-2.

Additional files

Editorial Notes