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NSTEMI - Non-ST Segment Elevation MISENIOR-RITANCT03052036

The British Heart Foundation SENIOR-RITA Trial

A study testing Coronary Angiography, Coronary revascularisation and Optimal Medical Therapy in people with NSTEMI - Non-ST Segment Elevation MI, run by Newcastle-upon-Tyne Hospitals NHS Trust at 40 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal MI Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
NSTEMI - Non-ST Segment Elevation MI
What is being tested?
Coronary Angiography, Coronary revascularisation and Optimal Medical Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,518 participants
Where
40 sitesUnited Kingdom
Study dates
Nov 2016to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Aged ≥ 75 years
  • Type 1 NSTEMI during index hospitalisation

Who cannot join

  • Patients presenting with STEMI or unstable angina
  • Patients with cardiogenic shock
  • Patients with known life expectancy <1 year
  • Patients in whom neither the patient nor the consultee are able and willing to provide written informed consent
  • Previous inclusion in the BHF SENIOR-RITA trial
  • Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United Kingdom40 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Basildon & Thurrock University Hospitals NHS Foundation Trust

    Basildon, SS16 5NL

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, FY3 8NR

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, BD9 6RJ

  • Broomfield Hospital, Mid Essex Hospitals NHS Trust

    Broomfield

  • Cumberland Infirmary, North Cumbria University Hospitals NHS Trust

    Carlisle, CA2 7HY

  • St Helier Hospital, Epsom & St Helier University Hospitals NHS Trust

    Carshalton

  • Chesterfield Royal Hospital NHS Foundation Trust

    Chesterfield, S44 5BL

  • County Durham & Darlington NHS Foundation Trust

    Darlington, DL3 6HX

  • Royal Derby Hospital, Derby Teaching Hospitals NHS Foundation Trust

    Derby, DE22 3NE

  • Ninewells Hospital, NHS Tayside

    Dundee, DD1 9SY

  • Lanarkshire East Kilbride NHS Foundation Trust

    East Kilbride, G75 8RG

  • East Sussex NHS Healthcare Trust

    Eastbourne, TN37 7RD

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • Gateshead Hospitals NHS Foundation Trust

    Gateshead, NE9 6SX

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Royal Alexandra Hospital

    Glasgow, PA2 9PN

  • North Tees and Hartlepool Foundation Trust

    Hartlepool, TS19 8PE

  • NHS Ayrshire & Arran

    Kilmarnock, KA2 0BE

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • United Lincolnshire Healthcare Trust

    Lincoln, LN2 5QY

  • London Royal Free, Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Hammersmith Hospital, Imperial College Healthcare NHS Trust

    London, W12 0HS

  • Chelsea and Westminster

    London

  • Wythenshawe Hospital, University Hospital of South Manchester NHS Foundation Trust

    Manchester, M23 9QZ

  • Borders General Hospital

    Melrose, TD69BS

  • South Tees NHS Foundation Trust

    Middlesbrough, TS4 3BW

  • The Newcastle Upon Tyne Hospital NHS Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Northumbria Healthcare NHS Foundation Trust

    North Shields, NE63 9JJ

  • Pennine Acute Hospitals NHS Trust

    Oldham, OL1 2JH

  • Plymouth Hospital, Plymouth Hospitals NHS Trust

    Plymouth

  • Royal Berkshire Hospital, Royal Berkshire Foundation NHS Trust

    Reading, RG 1 5AN

  • East Surrey Hospital, Surrey & Sussex NHS Trust

    Redhill, RH1 5RH

  • Salford Royal NHS Foundation Trust

    Salford

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S5 7AU

  • South Tyneside NHS Foundation Trust

    South Shields, NE34 0PL

  • City Hospitals Sunderland NHS Foundation Trust

    Sunderland, SR4 7TP

  • Torbay Hospital, Torbay & South Devon NHS Foundation Trust

    Torquay

  • Pinderfields General Hospital

    Wakefield, West Yorkshire, WF1 4DG

  • The York Hospital, York Teaching Hospital NHS Foundation Trust

    York, Y031 8HE

Other trials in United Kingdom

About this study

Official title: The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial

SENIOR-RITA is a multicentre prospective open-label trial randomizing patients presenting with type 1 NSTEMI aged ≥75 years between invasive and conservative treatment strategies, to compare time from randomisation to cardiovascular death or non-fatal MI

Read the detailed description

The population is getting older and heart artery disease is the biggest killer in the UK. Over recent years, there have been improvements in medications and technologies to treat it, but these have been primarily tested in younger patients. Previous research studies suggest that older patients (75 years and over) are not well represented in clinical research and these patients in particular those that are frail and those with co-morbidities are less likely to receive advanced medications and medical procedures. The current study will enrol patients 75 years and over, presenting with a heart attack. If patients agree to participate, they will be randomly allocated to one of two treatment groups. In the first group, patients will receive the latest medications recommended in heart attack. In the second group, in addition to these medications, patients will have coronary angiography. This will show whether they have any blockages in heart arteries. If appropriate, coronary revascularisation by percutaneous coronary intervention (PCI) commonly known as coronary angioplasty or coronary artery bypass grafting, sometimes called CABG (a surgical procedure in which a blood vessel from the leg, arm or chest is used to bypass a narrowed section of a coronary artery) will be carried out. During the trial, frailty scores, cognition measures, co-morbidity indices, questionnaires on quality of life, NHS and personal social services utilization will be collected from the participant and in addition proxy quality of life information will be collected from the participant's carers. Investigators will evaluate which one of the two treatment groups will do better and live longer. Investigators will also collect information on their quality of life and frailty measures for a 5 year period. The trial hopes to recruit 2300 patients from approximately 30 centres across the UK.

Being tested
Coronary Angiography, Coronary revascularisation, Optimal Medical Therapy
Keywords
Acute Coronary Syndrome
Medical subject headings
Non-ST Elevated Myocardial Infarction, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary AngiographyProcedure or surgery

    Coronary angiography to determine location of blocked or narrowed arteries.

  • Coronary revascularisationProcedure or surgery

    PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.

  • Optimal Medical TherapyOther

    Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.

Study groups in NCT03052036
Study groupRoleWhat they receive
Invasive TreatmentOtherCoronary angiography with a view to coronary revascularisation
Receives: Procedure: Coronary Angiography; Procedure: Coronary revascularisation; Other: Optimal Medical Therapy
Optimal Medical TherapyOtherPatients to be treated with guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE inhibitors, betabloackers
Receives: Other: Optimal Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization

    To determine the impact of a routine invasive strategy on cardiovascular death and non-fatal myocardial infarction (MI) compared with a conservative treatment strategy in older patients (≥75 years) with NSTEMI.

    Measured: Up to 5 years

Secondary outcomes (15)

  1. All cause, cardiovascular and non-cardiovascular death rates

    Measured: Up to 5 years

  2. Recurrent myocardial infarction

    Measured: Up to 5 years

  3. Hospitalisation for heart failure

    Measured: Up to 5 years

  4. Urgent coronary revascularisation

    Measured: Up to 5 years

  5. Recurrent hospitalisation for myocardial infarction

    Measured: Up to 5 years

  6. Stroke

    Measured: Up to 5 years

  7. Length of time spent at home

    Measured: Up to 5 years

  8. Fried and Rockwood frailty scores

    Measured: Up to 5 years

  9. Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)

    Quality of life will be measured using the EQ-5D-5L instrument[REF: The EuroQol Group (1990). EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16(3):199-208html ] (paper and telephone versions), with the results for each participant converted into quality-adjusted life-years (QALYs) using the area under the curve approach, a standard methodology for this process,[REF: Drummond MOB, B; Stoddart, G; Torrance, G. . Methods for the economic evaluation of Health Care Programmes: Oxford University Press 2005.] with the responses to the EQ-5D-5L scored using the appropriate value set for the United Kingdom, which is expected to be available by the time of the analysis. REF: Office for Health Economics. New OHE Publications: An EQ-5D-5L Value Set for England. Available at: https://www.ohe.org/news/new-ohe-publications-eq-5d-5l-value-set-england. Accessed February 03 2017]

    Measured: Up to 5 years

  10. Costs to the NHS and personal social services

    Measured: Up to 5 years

  11. Incremental cost per QALY gained at 1 year

    Measured: Up to 5 years

  12. Procedural complications

    Perforation, myocardial infarction (Type 4a), coronary dissection, TIA, Death in Cath Lab, Aortic dissection

    Measured: Within 7 days of invasive care

  13. Bleeding

    Bleeding according to BARC Criteria

    Measured: Up to 1 year

  14. Renal replacement therapy

    Need for renal replacement therapy

    Measured: Within 7 days of invasive care

  15. 25% increase in serum creatinine concentration

    25% increase in serum creatinine concentration from baseline (hospitalisation)

    Measured: Within 7 days of invasive care

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study startNov 2016
  3. Primary completion31 Mar 2024
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052036
Sponsor's protocol ID
7910
Acronym
SENIOR-RITA
Status last verified
Jul 2024
First submitted
11 Jan 2017
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Orimo H, Ito H, Suzuki T, Araki A, Hosoi T, Sawabe M. Reviewing the definition of "elderly". Geriatrics & Gerontology International. 2006;6:149-158

  • Townsend N, Wickramasinghe K, Bhatnagar P, Smolina K, Nichols M, Leal J, Luengo-Fernandez R, Rayner M. Coronary heart disease statistics 2012 edition. 2012

  • Machin D, Campbell MJ, Tan SB, Tan SH. Comparing survival curves. Sample size tables for clinical studies. Wiley-Blackwell; 2009:84-101.

  • Zaman MJ, Stirling S, Shepstone L, Ryding A, Flather M, Bachmann M, Myint PK. The association between older age and receipt of care and outcomes in patients with acute coronary syndromes: a cohort study of the Myocardial Ischaemia National Audit Project (MINAP). Eur Heart J. 2014 Jun 14;35(23):1551-8. doi: 10.1093/eurheartj/ehu039. Epub 2014 Mar 18.

    PubMed 24644310

  • Beecham J KM. Costing psychiatric interventions. In: Thornicroft, graham, ed. Measuring mental health needs (second edition). Royal college of psychiatrists, london, 2001, 200-224. Measuring Mental Health Needs 2001;Second Edition 24

  • Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30.

    PubMed 20359842

  • Fox KA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TR, Wheatley DJ, Pocock SJ; Randomized Intervention Trial of unstable Angina Investigators. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina. Lancet. 2002 Sep 7;360(9335):743-51. doi: 10.1016/s0140-6736(02)09894-x.

    PubMed 12241831

  • Goodman SG, Huang W, Yan AT, Budaj A, Kennelly BM, Gore JM, Fox KA, Goldberg RJ, Anderson FA Jr; Expanded Global Registry of Acute Coronary Events (GRACE2) Investigators. The expanded Global Registry of Acute Coronary Events: baseline characteristics, management practices, and hospital outcomes of patients with acute coronary syndromes. Am Heart J. 2009 Aug;158(2):193-201.e1-5. doi: 10.1016/j.ahj.2009.06.003.

    PubMed 19619694

  • Devlin G, Gore JM, Elliott J, Wijesinghe N, Eagle KA, Avezum A, Huang W, Brieger D; GRACE Investigators. Management and 6-month outcomes in elderly and very elderly patients with high-risk non-ST-elevation acute coronary syndromes: The Global Registry of Acute Coronary Events. Eur Heart J. 2008 May;29(10):1275-82. doi: 10.1093/eurheartj/ehn124. Epub 2008 Apr 2.

    PubMed 18387940

  • Nguyen HL, Goldberg RJ, Gore JM, Fox KA, Eagle KA, Gurfinkel EP, Spencer FA, Reed G, Quill A, Anderson FA Jr. Age and sex differences, and changing trends, in the use of evidence-based therapies in acute coronary syndromes: perspectives from a multinational registry. Coron Artery Dis. 2010 Sep;21(6):336-44. doi: 10.1097/MCA.0b013e32833ce07c.

    PubMed 20661139

  • Avezum A, Makdisse M, Spencer F, Gore JM, Fox KA, Montalescot G, Eagle KA, White K, Mehta RH, Knobel E, Collet JP; GRACE Investigators. Impact of age on management and outcome of acute coronary syndrome: observations from the Global Registry of Acute Coronary Events (GRACE). Am Heart J. 2005 Jan;149(1):67-73. doi: 10.1016/j.ahj.2004.06.003.

    PubMed 15660036

  • Alexander KP, Newby LK, Cannon CP, Armstrong PW, Gibler WB, Rich MW, Van de Werf F, White HD, Weaver WD, Naylor MD, Gore JM, Krumholz HM, Ohman EM; American Heart Association Council on Clinical Cardiology; Society of Geriatric Cardiology. Acute coronary care in the elderly, part I: Non-ST-segment-elevation acute coronary syndromes: a scientific statement for healthcare professionals from the American Heart Association Council on Clinical Cardiology: in collaboration with the Society of Geriatric Cardiology. Circulation. 2007 May 15;115(19):2549-69. doi: 10.1161/CIRCULATIONAHA.107.182615.

    PubMed 17502590

  • Hordijk-Trion M, Lenzen M, Wijns W, de Jaegere P, Simoons ML, Scholte op Reimer WJ, Bertrand ME, Mercado N, Boersma E; EHS-CR Investigators. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization. Eur Heart J. 2006 Mar;27(6):671-8. doi: 10.1093/eurheartj/ehi731. Epub 2006 Jan 19.

    PubMed 16423872

  • Granger CB, Goldberg RJ, Dabbous O, Pieper KS, Eagle KA, Cannon CP, Van De Werf F, Avezum A, Goodman SG, Flather MD, Fox KA; Global Registry of Acute Coronary Events Investigators. Predictors of hospital mortality in the global registry of acute coronary events. Arch Intern Med. 2003 Oct 27;163(19):2345-53. doi: 10.1001/archinte.163.19.2345.

    PubMed 14581255

  • Bagnall AJ, Goodman SG, Fox KA, Yan RT, Gore JM, Cheema AN, Huynh T, Chauret D, Fitchett DH, Langer A, Yan AT; Canadian Acute Coronary Syndrome Registry I and II Investigators; Canadian Global Registry of Acute Coronary Events (GRACE/GRACE2) Investigators. Influence of age on use of cardiac catheterization and associated outcomes in patients with non-ST-elevation acute coronary syndromes. Am J Cardiol. 2009 Jun 1;103(11):1530-6. doi: 10.1016/j.amjcard.2009.01.369. Epub 2009 Apr 8.

    PubMed 19463511

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Angiography, Coronary revascularisation and Optimal Medical Therapy in people with NSTEMI - Non-ST Segment Elevation MI, run by Newcastle-upon-Tyne Hospitals NHS Trust at 40 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052036, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

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