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Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
Phase 2 trial testing Ramipril in Myocardial Infarction in 295 participants. Completed in 8 July 2021.
| Lead sponsor | Quantum Genomics SA |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 295 |
| Start date | 4 June 2019 |
| Primary completion | 8 July 2021 |
| Estimated completion | 8 July 2021 |
| Sites | 7 locations across France, Slovakia, United Kingdom, Germany, Poland, Hungary, Spain |
Quantum Genomics SA — full company profile →
18 and older, any sex, with Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comparison of the effects of BID oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in LVEF on Day 84
| Group | Value | 95% CI |
|---|---|---|
| Group 1: Firibastat 100 mg | 5.6 | ± 1.2 |
| Group 2: Firibastat 500 mg | 5.3 | ± 1.1 |
| Group 3: Ramipril 5 mg | 5.7 | ± 1.1 |
Comparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in left-ventricle end-diastolic volume
| Group | Value | 95% CI |
|---|---|---|
| Group 1: Firibastat 100 mg | 14.2 | ± 4.5 |
| Group 2: Firibastat 500 mg | 12.7 | ± 4.3 |
| Group 3: Ramipril 5 mg | 9.4 | ± 4.4 |
Comparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in left-ventricle end-systolic volume
| Group | Value | 95% CI |
|---|---|---|
| Group 1: Firibastat 100 mg | -0.5 | ± 3.3 |
| Group 2: Firibastat 500 mg | -0.4 | ± 3.2 |
| Group 3: Ramipril 5 mg | -3.1 | ± 3.2 |
Comparison of the effects of BID administration of firibastat and ramipril on major cardiac event (MACE) over 84 days
| Group | Value | 95% CI |
|---|---|---|
| Group 1: Firibastat 100 mg | 10 | |
| Group 2: Firibastat 500 mg | 8 | |
| Group 3: Ramipril 5 mg | 6 |
Comparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in N-terminal pro b-type natriuretic peptide (NT proBNP)
| Group | Value | 95% CI |
|---|---|---|
| Group 1: Firibastat 100 mg | -1618.7 | ± 1381.7 |
| Group 2: Firibastat 500 mg | -1596.4 | ± 2279.6 |
| Group 3: Ramipril 5 mg | -1735.6 | ± 2326.5 |
Time frame: Adverse events collected from the ICF signature to the end of the study.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group 1: Firibastat 100 mg | Group 2: Firibastat 500 mg | Group 3: Ramipril 5 mg |
|---|---|---|---|---|
| Chest pain or chest discomfort (non cardiac) | General disorders | — | — | — |
| COVID19 | Infections and infestations | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — |
| Myocardial Infarction | Cardiac disorders | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — |
| Aortic valve incompetence | Cardiac disorders | — | — | — |
| Cardiac Arrest | Cardiac disorders | — | — | — |
| Cardiac tamponade | Cardiac disorders | — | — | — |
| Dressler's syndrome | Cardiac disorders | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — |
| Pericarditis | Cardiac disorders | — | — | — |
| Ventricule rupture | Cardiac disorders | — | — | — |
| Hyperplasia adrenal | Endocrine disorders | — | — | — |
| Retinal Detachment | Eye disorders | — | — | — |
| Death | General disorders | — | — | — |
| Vascular stent trombosis | General disorders | — | — | — |
| Staphylococcal Bacteraemia | Infections and infestations | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Limb injury | Injury, poisoning and procedural complications | — | — | — |
| Periprocedural myocadial infarction | Injury, poisoning and procedural complications | — | — | — |
| Electrocardiogram QT prolonged | Investigations | — | — | — |
| Spinal pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Reaction | System | Group 1: Firibastat 100 mg | Group 2: Firibastat 500 mg | Group 3: Ramipril 5 mg |
|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| Chest disconfort | General disorders | — | — | — |
| Chest pain | General disorders | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — |
| Cardiac failure | Cardiac disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — |
| Liver disorder | Hepatobiliary disorders | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — |
| Dressler's syndrome | Cardiac disorders | — | — | — |
| Pericardial effusion | Cardiac disorders | — | — | — |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | — | — | — |
| Drug eruption | Skin and subcutaneous tissue disorders | — | — | — |
| Ecchymosis | Skin and subcutaneous tissue disorders | — | — | — |
| Skin exfoliation | Skin and subcutaneous tissue disorders | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — |
| Orthostatic hypotension | Vascular disorders | — | — | — |
| Peripheral swelling | General disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Spinal Pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Lip swelling | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dypsnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| ECG QT prolonged | Investigations | — | — | — |
Most-reported serious reactions: Chest pain or chest discomfort (non cardiac), COVID19, Anemia, Cardiac failure, Coronary artery disease, Acute kidney injury, Myocardial Infarction, Angina pectoris.
Data from ClinicalTrials.gov NCT03715998 adverse events section.
This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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