Condition category
Circulatory System
Date applied
16/11/2001
Date assigned
16/11/2001
Last edited
03/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rita3.org.uk

Contact information

Type

Scientific

Primary contact

Prof Keith AA Fox

ORCID ID

Contact details

Chancellor's Buiding
49 Little France Crescent
Edinburgh
EH16 4SB
United Kingdom
+44 (0)131 536 2743
k.a.a.fox@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG/96001

Study information

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])

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

Multi-centre national ethics committee approval and local ethics committee approval were obtained

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found on the website at: http://www.rita3.org.uk/

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

Phase

Drug names

Primary outcome measures

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 trial start date

12/11/1997

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

1810

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

United Kingdom

Trial participating centre

The University of Edinburgh
Edinburgh
EH16 4SB
United Kingdom

Sponsor information

Organisation

British Heart Foundation (UK)

Sponsor details

14 Fitzhardinge Street
London
W1H 6DH
United Kingdom
+44 (0)20 7935 0185
research@bhf.org.uk

Sponsor type

Charity

Website

http://www.bhf.org.uk

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK) (ref: RG/96001) - plus donation from Aventis to the British Heart Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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
9. 2015 10-year results in: http://www.ncbi.nlm.nih.gov/pubmed/26227188

Publication citations

  1. Results of impact of gender

    Clayton TC, Pocock SJ, Henderson RA, Poole-Wilson PA, Shaw TR, Knight R, Fox KA, Do men benefit more than women from an interventional strategy in patients with unstable angina or non-ST-elevation myocardial infarction? The impact of gender in the RITA 3 trial., Eur. Heart J., 2004, 25, 18, 1641-1650, doi: 10.1016/j.ehj.2004.07.032.

  2. Patient management and disease events results

    Poole-Wilson PA, Pocock SJ, Fox KA, Henderson RA, Wheatley DJ, Chamberlain DA, Shaw TR, Clayton TC, , Interventional versus conservative treatment in acute non-ST elevation coronary syndrome: time course of patient management and disease events over one year in the RITA 3 trial., Heart, 2006, 92, 10, 1473-1479, doi: 10.1136/hrt.2005.060541.

  3. Cost effectiveness study results

    Henriksson M, Epstein DM, Palmer SJ, Sculpher MJ, Clayton TC, Pocock SJ, Henderson RA, Buxton MJ, Fox KA, The cost-effectiveness of an early interventional strategy in non-ST-elevation acute coronary syndrome based on the RITA 3 trial., Heart, 2008, 94, 6, 717-723, doi: 10.1136/hrt.2007.127340.

  4. Collaborative analysis

    Damman P, Clayton T, Wallentin L, Lagerqvist B, Fox KA, Hirsch A, Windhausen F, Swahn E, Pocock SJ, Tijssen JG, de Winter RJ, Effects of age on long-term outcomes after a routine invasive or selective invasive strategy in patients presenting with non-ST segment elevation acute coronary syndromes: a collaborative analysis of individual data from the FRISC II - ICTUS - RITA-3 (FIR) trials., Heart, 2012, 98, 3, 207-213, doi: 10.1136/heartjnl-2011-300453.

  5. Collaborative analysis

    Damman P, Wallentin L, Fox KA, Windhausen F, Hirsch A, Clayton T, Pocock SJ, Lagerqvist B, Tijssen JG, de Winter RJ, Long-term cardiovascular mortality after procedure-related or spontaneous myocardial infarction in patients with non-ST-segment elevation acute coronary syndrome: a collaborative analysis of individual patient data from the FRISC II, ICTUS, and RITA-3 trials (FIR)., Circulation, 2012, 125, 4, 568-576, doi: 10.1161/CIRCULATIONAHA.111.061663.

  6. Collaborative analysis

    Damman P, van Geloven N, Wallentin L, Lagerqvist B, Fox KA, Clayton T, Pocock SJ, Hirsch A, Windhausen F, Tijssen JG, de Winter RJ, Timing of angiography with a routine invasive strategy and long-term outcomes in non-ST-segment elevation acute coronary syndrome: a collaborative analysis of individual patient data from the FRISC II (Fragmin and Fast Revascularization During Instability in Coronary Artery Disease), ICTUS (Invasive Versus Conservative Treatment in Unstable Coronary Syndromes), and RITA-3 (Intervention Versus Conservative Treatment Strategy in Patients With Unstable Angina or Non-ST Elevation Myocardial Infarction) Trials., JACC Cardiovasc Interv, 2012, 5, 2, 191-199, doi: 10.1016/j.jcin.2011.10.016.

  7. Fox KA, Poole-Wilson P, Clayton TC, Henderson RA, Shaw TR, Wheatley DJ, Knight R, Pocock SJ, 5-year outcome of an interventional strategy in non-ST-elevation acute coronary syndrome: the British Heart Foundation RITA 3 randomised trial., Lancet, 366, 9489, 914-920, doi: 10.1016/S0140-6736(05)67222-4.

  8. Kim J, Henderson RA, Pocock SJ, Clayton T, Sculpher MJ, Fox KA, , Health-related quality of life after interventional or conservative strategy in patients with unstable angina or non-ST-segment elevation myocardial infarction: one-year results of the third Randomized Intervention Trial of unstable Angina (RITA-3)., J. Am. Coll. Cardiol., 2005, 45, 2, 221-228, doi: 10.1016/j.jacc.2004.10.034.

  9. Results

    Henderson RA, Jarvis C, Clayton T, Pocock SJ, Fox KA, 10-Year Mortality Outcome of a Routine Invasive Strategy Versus a Selective Invasive Strategy in Non-ST-Segment Elevation Acute Coronary Syndrome: The British Heart Foundation RITA-3 Randomized Trial, J Am Coll Cardiol, 2015, 66, 5, 511-520, doi: 10.1016/j.jacc.2015.05.051.

Additional files

Editorial Notes