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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 10.1186/ISRCTN07752711
ClinicalTrials.gov identifier
EudraCT number
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
Serial number at source RG/96001
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.
Lay summary Not provided at time of registration
Ethics approval Multi-centre national ethics committee approval and local ethics committee approval were obtained.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Unstable angina/non-ST elevation myocardial infarction
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.
Anticipated start date 12/11/1997
Anticipated end date 31/12/2006
Status of trial Completed
Patient information material Patient information can be found on the website at: http://www.rita3.org.uk/
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.
Sources of funding British Heart Foundation (UK) (ref: RG/96001) - plus donation from Aventis to the British Heart Foundation
Trial website http://www.rita3.org.uk
Publications Results in:
1. 2004 results of impact of gender in http://www.ncbi.nlm.nih.gov/pubmed/15351164
2. 2005 five-year outcomes results in http://www.ncbi.nlm.nih.gov/pubmed/16154018
3. 2005 one-year results in http://www.ncbi.nlm.nih.gov/pubmed/15653019
4. 2006 patient management and disease events results in http://www.ncbi.nlm.nih.gov/pubmed/16621882
5. 2008 cost effectiveness study results in http://www.ncbi.nlm.nih.gov/pubmed/18032459
6. 2012 collaborative analysis in http://www.ncbi.nlm.nih.gov/pubmed/21930723
7. 2012 collaborative analysis in http://www.ncbi.nlm.nih.gov/pubmed/22199015
8. 2012 collaborative analysis in http://www.ncbi.nlm.nih.gov/pubmed/22361604
Contact name Prof  Keith AA  Fox
  Address Chancellor's Buiding
49 Little France Crescent
  City/town Edinburgh
  Zip/Postcode EH16 4SB
  Country United Kingdom
  Tel +44 (0)131 536 2743
  Fax +44 (0)131 536 2744
  Email k.a.a.fox@ed.ac.uk
Sponsor British Heart Foundation (UK)
  Address 14 Fitzhardinge Street
  City/town London
  Zip/Postcode W1H 6DH
  Country United Kingdom
  Tel +44 (0)20 7935 0185
  Fax +44 (0)20 7486 5820
  Email research@bhf.org.uk
  Sponsor website: http://www.bhf.org.uk
Date applied 16/11/2001
Last edited 13/07/2012
Date ISRCTN assigned 16/11/2001
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