Cambridge Heart Antioxidant Study
| ISRCTN | ISRCTN74843649 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74843649 |
| Protocol serial number | N/A |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Eastern (UK) |
- 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
Scientific
Cardiology Department
Northwick Park Hospital
Harrow
Middlesex
HA1 3UJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS) |
| Study acronym | CHAOS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cardiovascular death and non-fatal MI as well as non-fatal MI alone |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 18/06/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 2002 |
| Key inclusion criteria | Patients with angiographically proven coronary atherosclerosis |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/10/1992 |
| Date of final enrolment | 18/06/1995 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cardiology Department
Middlesex
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
