The British Heart Foundation SENIOR-RITA Trial

NCT03052036 | Active Not Recruiting DMC

• 1 other identifier: 7910
• Study Type: interventional
• Target: 1,518
• Locations: 1 country
• Sites: 40

Brief 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

Conditions

NSTEMI - Non-ST Segment Elevation MI

Keywords

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (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.

  Up to 5 years

Secondary Outcomes (15)

• All cause, cardiovascular and non-cardiovascular death rates

  Up to 5 years

• Recurrent myocardial infarction

  Up to 5 years

• Hospitalisation for heart failure

  Up to 5 years

• Urgent coronary revascularisation

  Up to 5 years

• Recurrent hospitalisation for myocardial infarction

  Up to 5 years

Study Arms (2)

Invasive Treatment

OTHER

Coronary angiography with a view to coronary revascularisation

Procedure: Coronary Angiography; Procedure: Coronary revascularisation; Other: Optimal Medical Therapy

Optimal Medical Therapy

OTHER

Patients to be treated with guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE inhibitors, betabloackers

Other: Optimal Medical Therapy

Interventions

Coronary Angiography PROCEDURE

Coronary angiography to determine location of blocked or narrowed arteries.

Invasive Treatment

Coronary revascularisation PROCEDURE

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

Invasive Treatment

Optimal Medical Therapy OTHER

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

Invasive Treatment; Optimal Medical Therapy

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Inability to undergo invasive coronary angiography, such as no vascular access site, or absolute contraindication to coronary revascularisation

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• British Heart Foundation: collaborator
• Newcastle University: collaborator

Study Sites (40)

Pinderfields General Hospital

Wakefield, West Yorkshire, WF1 4DG, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Basildon & Thurrock University Hospitals NHS Foundation Trust

Basildon, SS16 5NL, United Kingdom

Location

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, FY3 8NR, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6RJ, United Kingdom

Location

Broomfield Hospital, Mid Essex Hospitals NHS Trust

Broomfield, United Kingdom

Location

Cumberland Infirmary, North Cumbria University Hospitals NHS Trust

Carlisle, CA2 7HY, United Kingdom

Location

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

Carshalton, United Kingdom

Location

Chesterfield Royal Hospital NHS Foundation Trust

Chesterfield, S44 5BL, United Kingdom

Location

County Durham & Darlington NHS Foundation Trust

Darlington, DL3 6HX, United Kingdom

Location

Royal Derby Hospital, Derby Teaching Hospitals NHS Foundation Trust

Derby, DE22 3NE, United Kingdom

Location

Ninewells Hospital, NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

Lanarkshire East Kilbride NHS Foundation Trust

East Kilbride, G75 8RG, United Kingdom

Location

East Sussex NHS Healthcare Trust

Eastbourne, TN37 7RD, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Gateshead Hospitals NHS Foundation Trust

Gateshead, NE9 6SX, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Royal Alexandra Hospital

Glasgow, PA2 9PN, United Kingdom

Location

North Tees and Hartlepool Foundation Trust

Hartlepool, TS19 8PE, United Kingdom

Location

NHS Ayrshire & Arran

Kilmarnock, KA2 0BE, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

United Lincolnshire Healthcare Trust

Lincoln, LN2 5QY, United Kingdom

Location

London Royal Free, Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Chelsea and Westminster

London, United Kingdom

Location

Wythenshawe Hospital, University Hospital of South Manchester NHS Foundation Trust

Manchester, M23 9QZ, United Kingdom

Location

Borders General Hospital

Melrose, TD69BS, United Kingdom

Location

South Tees NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

The Newcastle Upon Tyne Hospital NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

North Shields, NE63 9JJ, United Kingdom

Location

Pennine Acute Hospitals NHS Trust

Oldham, OL1 2JH, United Kingdom

Location

Plymouth Hospital, Plymouth Hospitals NHS Trust

Plymouth, United Kingdom

Location

Royal Berkshire Hospital, Royal Berkshire Foundation NHS Trust

Reading, RG 1 5AN, United Kingdom

Location

East Surrey Hospital, Surrey & Sussex NHS Trust

Redhill, RH1 5RH, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S5 7AU, United Kingdom

Location

South Tyneside NHS Foundation Trust

South Shields, NE34 0PL, United Kingdom

Location

City Hospitals Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

Location

Torbay Hospital, Torbay & South Devon NHS Foundation Trust

Torquay, United Kingdom

Location

The York Hospital, York Teaching Hospital NHS Foundation Trust

York, Y031 8HE, United Kingdom

Location

Related Publications (38)

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Related Links

• Organisation WH.

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Dr Vijay Kunadian, MBBS MD FRCP

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: February 14, 2017
• Study Start: November 1, 2016
• Primary Completion: March 31, 2024
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

GB (40)