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ISRCTN
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ISRCTN07752711
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ClinicalTrials.gov identifier
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Public title
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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])
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Scientific title
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Acronym
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RITA 3
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Serial number at source
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RG/96001
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Study hypothesis
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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.
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Ethics approval
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Multi-centre national ethics committee approval and local ethics committee approval were obtained.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Unstable angina/non-ST elevation myocardial infarction
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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12/11/1997
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Anticipated end date
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31/12/2006
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Status of trial
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Completed
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Patient information material
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Patient information can be found on the website at: http://www.rita3.org.uk/
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Target number of participants
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1810
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Interventions
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Angiography followed by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG) versus conservative management.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Secondary outcomes included subsequent revascularisation, angina scores, anti-anginal medication, quality-of-life scores, and health-economic evaluations.
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Sources of funding
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British Heart Foundation (UK) (ref: RG/96001) - plus donation from Aventis to the British Heart Foundation
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Trial website
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http://www.rita3.org.uk
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Publications
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Results in:
1. Impact of gender: http://www.ncbi.nlm.nih.gov/pubmed/15351164
2. Five-year outcomes: http://www.ncbi.nlm.nih.gov/pubmed/16154018
3. One-year results: http://www.ncbi.nlm.nih.gov/pubmed/15653019
4. Patient management and disease events: http://www.ncbi.nlm.nih.gov/pubmed/16621882
5. Cost effectiveness study: http://www.ncbi.nlm.nih.gov/pubmed/18032459
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Contact name
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Prof
Keith AA
Fox
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Address
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Chancellor's Buiding
49 Little France Crescent
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SB
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Country
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United Kingdom
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Tel
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+44 (0)131 536 2743
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Fax
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+44 (0)131 536 2744
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Email
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k.a.a.fox@ed.ac.uk
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Sponsor
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British Heart Foundation (UK)
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Address
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14 Fitzhardinge Street
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City/town
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London
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Zip/Postcode
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W1H 6DH
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Country
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United Kingdom
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Tel
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+44 (0)20 7935 0185
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Fax
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+44 (0)20 7486 5820
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Email
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research@bhf.org.uk
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Sponsor website:
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http://www.bhf.org.uk
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Date applied
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16/11/2001
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Last edited
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16/05/2008
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Date ISRCTN assigned
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16/11/2001
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