ARNI versus ACE inhibition to reduce Heart Failure events after an MI
Research type
Research Study
Full title
A multi-centre, randomised, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction.
IRAS ID
209045
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2016-002154-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 9 days
Research summary
A Heart Attack, known as acute myocardial infarction (AMI) is one of the most common heart related reasons people are hospitalised. The number of people dying in hospital from an AMI has decreased as a result of more frequent use of therapies which restore blood flow to the heart. Due to more people surviving a heart attack, the number of people developing heart failure (HF), a common complication following an AMI, has increased. Data from registries and clinical trials show the need for more therapeutic approaches to reduce HF-related illness and death in post-AMI patients.
The aim of this study is to see whether a new drug, LCZ696 is safe and effective in preventing cardiovascular death or heart failure hospitalisation compared to ramipril after AMI. Eligible patients who agree and consent to take part in the study will continue on their regular therapy for their condition but any Angiotensin II receptor blockers (ARBs) and angiotensin converting enzyme inhibitor (ACEI) will be replaced by the study medication.
Patients who meet the entry criteria will be randomly allocated to receive LCZ696 or ramipril as well as their usual treatment post MI, in a double blind fashion. This means neither the doctor nor the patient will know which has been allocated.
Although the exact number of visits will depend on when the study reaches its required number of events, it is planned that patients will be in the study for about 2 years 8 months, and will visit the clinic approximately 14 times. The main assessments will include physical examinations, blood pressure and pulse measurements, safety blood and urine tests and completion of questionnaires to assess impact of heart failure on patients’ quality of life.
Approximately 4,650 patients from across the world will be recruited into this study, of which approximately 100 will be from the UK.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0384
Date of REC Opinion
6 Dec 2016
REC opinion
Favourable Opinion