Intervention versus conservative treatment strategy in patients with unstable angina or non-ST elevation myocardial infarction (the Third Randomised Intervention Treatment of Angina trials [RITA 3])
| ISRCTN | ISRCTN07752711 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07752711 |
| Secondary identifying numbers | RG/96001 |
- Submission date
- 16/11/2001
- Registration date
- 16/11/2001
- Last edited
- 03/08/2015
- 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
Not provided at time of registration
Contact information
Prof Keith AA Fox
Scientific
Scientific
Chancellor's Buiding
49 Little France Crescent
Edinburgh
EH16 4SB
United Kingdom
| Phone | +44 (0)131 536 2743 |
|---|---|
| k.a.a.fox@ed.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found on the website at: http://www.rita3.org.uk/ |
| Scientific title | Intervention versus conservative treatment strategy in patients with unstable angina or non-ST elevation myocardial infarction (the Third Randomised Intervention Treatment of Angina trials [RITA 3]) |
| Study acronym | RITA 3 |
| Study hypothesis | Current guidelines suggest that, for patients at moderate risk of death from unstable coronary-artery disease, either an interventional strategy (angiography followed by revascularisation) or a conservative strategy (ischaemia-driven or symptom-driven angiography) is appropriate. We aimed to test the hypothesis that an interventional strategy is better than a conservative strategy in such patients. |
| Ethics approval(s) | Multi-centre national ethics committee approval and local ethics committee approval were obtained |
| Condition | Unstable angina/non-ST elevation myocardial infarction |
| Intervention | Angiography followed by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) versus conservative management. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The co-primary endpoints were a combined rate of death, non-fatal myocardial infarction, or refractory angina at 4 months; and a combined rate of death or non-fatal myocardial infarction at 1 year. Analysis was by intention to treat. |
| Secondary outcome measures | Secondary outcomes included subsequent revascularisation, angina scores, anti-anginal medication, quality-of-life scores, and health-economic evaluations. |
| Overall study start date | 12/11/1997 |
| Overall study end date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1810 |
| Participant inclusion criteria | Patients within 24 hours of an index episode of ischaemic pain at rest or patients will have documented evidence of coronary disease with at least one of: 1. Electrocardiogram (ECG) evidence of myocardial ischaemia 2. Pathological Q waves on an ECG suggesting previous myocardial infarction 3. Arteriographically proven coronary disease on a previous angiogram |
| Participant exclusion criteria | All those with probable evolving myocardial infarction, including those for whom reperfusion therapy was indicated, were ineligible. Those in A1 whom new pathological Q waves developed, or those with creatine kinase or creatine kinase Myocardial Bands (MB) concentrations twice the upper limit of normal before randomisation, were excluded. Also excluded were those with myocardial infarction within the previous month, Percutaneous Coronary Intervention (PCI) in the preceding 12 months, or Coronary Artery Bypass Grafting (CABG) at any time. |
| Recruitment start date | 12/11/1997 |
| Recruitment end date | 31/12/2006 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
The University of Edinburgh
Edinburgh
EH16 4SB
United Kingdom
EH16 4SB
United Kingdom
Sponsor information
British Heart Foundation (UK)
Charity
Charity
14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
| Phone | +44 (0)20 7935 0185 |
|---|---|
| research@bhf.org.uk | |
| Website | http://www.bhf.org.uk |
"ROR" |
https://ror.org/02wdwnk04 |
Funders
Funder type
Charity
British Heart Foundation (UK) (ref: RG/96001) - plus donation from Aventis to the British Heart Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 of impact of gender | 01/09/2004 | Yes | No | |
| Results article | one-year results | 18/01/2005 | Yes | No | |
| Results article | five-year outcomes results | 01/09/2005 | Yes | No | |
| Results article | patient management and disease events results | 01/10/2006 | Yes | No | |
| Results article | cost effectiveness study results | 01/06/2008 | Yes | No | |
| Other publications | collaborative analysis | 31/01/2012 | Yes | No | |
| Other publications | collaborative analysis | 01/02/2012 | Yes | No | |
| Other publications | collaborative analysis | 01/02/2012 | Yes | No | |
| Results article | 10-year results | 04/08/2015 | Yes | No |
