| Source of record | UK Trials |
| ISRCTN | ISRCTN07752711 |
| Date ISRCTN assigned | 16/11/2001 |
| Local reference number(s) | RG/96001 |
| Public 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]) |
| Scientific title |
|
| Acronym | RITA 3 |
| Disease/condition/study domain | Unstable angina/non-ST elevation myocardial infarction |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Multi-centre national ethics committee approval and local ethics committee approval were obtained. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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. |
| Patient information material | Patient information can be found on the website at: http://www.rita3.org.uk/ |
| Anticipated start date | 12/11/1997 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Target number of participants | 1810 |
| Interventions | Angiography followed by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) versus conservative management. |
| Primary outcome measure(s) | 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 measure(s) | Secondary outcomes included subsequent revascularisation, angina scores, anti-anginal medication, quality-of-life scores, and health-economic evaluations. |
| Trial website | http://www.rita3.org.uk |
| Publications | Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=15351164
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16154018
3. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=15653019
4. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=16621882 |
| Sources of funding | British Heart Foundation (UK) (ref: RG/96001) - plus donation from Aventis to the British Heart Foundation |
| Sponsor name | British Heart Foundation (UK) |
| Sponsor details | 14 Fitzhardinge Street
London
United Kingdom
W1H 6DH |
| Sponsor telephone | +44 (0)20 7935 0185 |
| Sponsor fax | +44 (0)20 7486 5820 |
| Sponsor email | research@bhf.org.uk |
| Sponsor website | http://www.bhf.org.uk |
| Contact name | Prof Keith AA Fox |
| Contact details | Chancellor's Buiding
49 Little France Crescent
Edinburgh
United Kingdom
EH16 4SB |
| Contact telephone | +44 (0)131 536 2743 |
| Contact fax | +44 (0)131 536 2744 |
| Contact email | k.a.a.fox@ed.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN07752711 |
| Date last extracted from ISRCTN register | 17/04/2008 |
