The British Heart Foundation SENIOR-RITA Trial

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Active, not recruiting

Conditions: NSTEMI - Non-ST Segment Elevation MI

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03052036

7910 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,518 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,518 participants in 2 patient groups

Invasive Treatment

Other group

Description:

Coronary angiography with a view to coronary revascularisation

Treatment:

Other: Optimal Medical Therapy

Procedure: Coronary Angiography

Procedure: Coronary revascularisation

Optimal Medical Therapy

Other group

Description:

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

Treatment:

Other: Optimal Medical Therapy