Clinical trial NCT03052036: The British Heart Foundation SENIOR-RITA Trial
Official title: The British Heart Foundation Older Patients With Non-ST SEgmeNt elevatIOn myocaRdial Infarction Randomized Interventional TreAtment Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: NSTEMI - Non-ST Segment Elevation MI
Keywords: Acute Coronary Syndrome
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: Newcastle University
First posted: 2017-02-14
Enrollment: 1518
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to cardiovascular death or non-fatal MI (defined by the fourth universal definition) from randomization
timeFrame: Up to 5 years
Secondary outcomes:
measure: All cause, cardiovascular and non-cardiovascular death rates
timeFrame: Up to 5 years
measure: Recurrent myocardial infarction
timeFrame: Up to 5 years
measure: Hospitalisation for heart failure
timeFrame: Up to 5 years
measure: Urgent coronary revascularisation
timeFrame: Up to 5 years
measure: Recurrent hospitalisation for myocardial infarction
timeFrame: Up to 5 years
measure: Stroke
timeFrame: Up to 5 years
measure: Length of time spent at home
timeFrame: Up to 5 years
measure: Fried and Rockwood frailty scores
timeFrame: Up to 5 years
measure: Quality of Life using EQ-5D-5L and quality adjusted life years (QALY)
timeFrame: Up to 5 years
measure: Costs to the NHS and personal social services
timeFrame: Up to 5 years
measure: Incremental cost per QALY gained at 1 year
timeFrame: Up to 5 years
measure: Procedural complications
timeFrame: Within 7 days of invasive care
measure: Bleeding
timeFrame: Up to 1 year
measure: Renal replacement therapy
timeFrame: Within 7 days of invasive care
measure: 25% increase in serum creatinine concentration
timeFrame: Within 7 days of invasive care
Other outcomes:
Locations:
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital
state: West Yorkshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Basildon
country: United Kingdom
facility: Basildon & Thurrock University Hospitals NHS Foundation Trust
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Broomfield
country: United Kingdom
facility: Broomfield Hospital, Mid Essex Hospitals NHS Trust
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary, North Cumbria University Hospitals NHS Trust
city: Carshalton
country: United Kingdom
facility: St Helier Hospital, Epsom & St Helier University Hospitals NHS Trust
city: Chesterfield
country: United Kingdom
facility: Chesterfield Royal Hospital NHS Foundation Trust
city: Darlington
country: United Kingdom
facility: County Durham & Darlington NHS Foundation Trust
city: Derby,
country: United Kingdom
facility: Royal Derby Hospital, Derby Teaching Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital, NHS Tayside
city: East Kilbride
country: United Kingdom
facility: Lanarkshire East Kilbride NHS Foundation Trust
city: Eastbourne
country: United Kingdom
facility: East Sussex NHS Healthcare Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Gateshead
country: United Kingdom
facility: Gateshead Hospitals NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Glasgow
country: United Kingdom
facility: Royal Alexandra Hospital
city: Hartlepool
country: United Kingdom
facility: North Tees and Hartlepool Foundation Trust
city: Kilmarnock
country: United Kingdom
facility: NHS Ayrshire & Arran
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Healthcare Trust
city: London
country: United Kingdom
facility: London Royal Free, Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital, University Hospital of South Manchester NHS Foundation Trust
city: Melrose
country: United Kingdom
facility: Borders General Hospital
city: Middlesbrough
country: United Kingdom
facility: South Tees NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospital NHS Foundation Trust
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Oldham
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospital, Plymouth Hospitals NHS Trust
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital, Royal Berkshire Foundation NHS Trust
city: Redhill
country: United Kingdom
facility: East Surrey Hospital, Surrey & Sussex NHS Trust
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: South Shields
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS Foundation Trust
city: Torquay
country: United Kingdom
facility: Torbay Hospital, Torbay & South Devon NHS Foundation Trust
city: York
country: United Kingdom
facility: The York Hospital, York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Newcastle University
name: Dr Vijay Kunadian, MBBS MD FRCP
role: PRINCIPAL_INVESTIGATOR
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