QGC001 or Ramipril after acute MI for prevention of LVD.
Research type
Research Study
Full title
A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat (QGC001) Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction after Acute Myocardial Infarction
IRAS ID
259906
Contact name
Bruno Besse
Contact email
Sponsor organisation
Quantum Genomics
Eudract number
2018-003146-17
Duration of Study in the UK
1 years, 7 months, days
Research summary
Research Summary:
This study will compare a new study drug called firibastat with a standard of care drug called ramipril in patients who have had a myocardial infarction. Myocardial infarction (or MI for short) is the medical name for a heart attack, which occurs when blood flow to a part of the heart decreases or stops, causing damage to the heart muscle.Firibastat and ramipril are drugs both designed to prevent heart failure following an MI by reducing blood pressure so that there is less strain on circulatory system. However, both drugs have a different way of doing this and are made in a different way. The main purpose of the study will be to compare the safety and effectiveness both drugs.
Following MI, participants will be randomised to receive either firibastat or ramipril for a duration of 12 weeks. Ramdomised mean that the participant will be assigned their study treatment completely by chance (like flipping a coin). The study is double blinded meaning that the participants and the researchers will not know which treatment has been assigned. There will be treatment 3 groups:
Group 1 will receive 50mgs of firibastat for two weeks followed by 100mgs for 10 weeks.
Group 2 will receive 250mg firibastat for 2 weeks followed by 500mgs for 10 weeks.
Group 3 will receive 2.5mg of ramipril for 2 weeks followed by 5mgs for 10 weeks.The assigned study treatment will be given by mouth (capsules which look identicle).
Study duration is expected to last for a maximum of about 89 days over 5 study visits. At these visits participants will be monitored to see how well they are tolerating the study treatment and will undergo standard procedures/tests in order to check for safety and effectiveness.About 294 participants will take part in this clinical study across the UK, Europe and the USA.
Summary of Results:
QUORUM study was a double-blind, randomized, active-controlled, European trial to assess efficacy of firibastat, first amino-peptidase inhibitor, versus ramipril in left ventricular dysfunction after acute myocardial infarction.
294 patients have been randomized within 24 hours after fist acute anterior myocardial infarction and treated with firibastat 100 mg twice-a-day, firibastat 500 mg twice-a-day or ramipril 5 mg twice-a-day (controlled group) for 12 weeks.
No difference in change from baseline in left ventricular ejection fraction assessed by cardiac Magnetic Resonance Imaging (MRI) was found between the 3 groups (primary endpoint) and in all other MRI parameters.
Occurrence of treatment-related adverse event was similar in the 3 groups. Most common side effect with firibastat was skin reactions.
In conclusion, firibastat (100 mg twice-a-day or 500mg twice-a-day) was not superior to ramipril to prevent left ventricular dysfunction after first acute anterior myocardial infarction. Firibastat had a similar safety profile to that of ramipril.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0247
Date of REC Opinion
27 Sep 2019
REC opinion
Further Information Favourable Opinion