Myocardial InfarctionPhase 2QUORUMNCT03715998
Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
A Phase 2 study testing Ramipril and Firibastat in people with Myocardial Infarction, run by Quantum Genomics SA at 7 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Ramipril and Firibastat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 4 Jun 2019to 8 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1 V6).
- Primary PCI of the index-MI-related artery within 24 hours after the MI.
Who cannot join
- Body mass index >45 kg/m².
- Subject is hemodynamically unstable or has cardiogenic shock.
- Subjects with clinical signs of HF (Kilipp III and IV).
- Systolic blood pressure <100 mmHg at inclusion visit
- Early primary PCI of the index-MI-related artery performed within 3 hours after MI.
- Subjects treated with angiotensin-converting-enzyme inhibitor (ACE I), angiotensin receptor blocker (ARB) or sacubitril/valsartan prior to the index magnetic resonance imaging. Note: if treatment was for HTN, ACE I/ARB should be stopped, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
- Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
France1 site
Groupe Hospitalier Pitie-Salpêtrière - Institut de Cardiologie
Paris, 75013
About this study
Official title: A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI
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.
Read the detailed description
At Inclusion Visit (Visit 2 [within 72 hours after acute MI]), subjects will be randomly assigned to 1 of the following 3 treatment groups in a 1:1:1 ratio:
- Group 1: Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks
- Group 2: Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks
- Group 3: Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks
Then subjects will undergo study procedures at Titration Visit (Visit 3 [Day 14]), Treatment Visit (Visit 4 Day 42]) and End-of-Treatment Visit (Visit 5 [Day 84]).
- Conditions
- Myocardial Infarction
- Being tested
- Ramipril, Firibastat
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
1 or 2 capsules administered orally, twice daily
FiribastatDrug
Also called QGC001
1 or 2 capsules administered orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1: firibastat 100 mg | Experimental | Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks. Receives: Drug: Firibastat |
| Group 2: firibastat 500 mg | Experimental | Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks. Receives: Drug: Firibastat |
| Group 3: ramipril 5 mg | Active comparator | Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks. Receives: Drug: Ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI)
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
Measured: 84 days
Secondary outcomes (4)
Left-ventricle End-diastolic Volume Assessed by CMRI
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
Measured: 84 days
Left-ventricle End-systolic Volume Assessed by CMRI
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
Measured: 84 days
Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization
Comparison of the effects of BID administration of firibastat and ramipril on major cardiac event (MACE) over 84 days
Measured: 84 days
N-terminal Pro B-type Natriuretic Peptide (NT proBNP)
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)
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start4 Jun 2019
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilles Montalescot, MD, PhD, Principal investigator, Groupe Hospitalier Pitié-Salpêtrière - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715998
- Sponsor's protocol ID
- QGC001-2QG4
- Acronym
- QUORUM
- Status last verified
- Dec 2020
- First submitted
- 19 Oct 2018
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montalescot G, Alexander JH, Cequier-Fillat A, Solomon SD, Redheuil A, Hudec M, Silvain J, Kachenoura N, Janas A, Orban M, Josse I, Balavoine F, Besse B. Firibastat Versus Ramipril After Acute Mechanical Reperfusion of Anterior Myocardial Infarction: A Phase 2 Study. Am J Cardiovasc Drugs. 2023 Mar;23(2):207-217. doi: 10.1007/s40256-023-00567-8. Epub 2023 Feb 9.
PubMed 36757536Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
PubMed 33027067
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI
- ClinicalTrials.gov ID
- NCT03715998
- Acronym / sponsor ID
- QUORUM / QGC001-2QG4
- Conditions
- Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At Inclusion Visit (Visit 2 [within 72 hours after acute MI]), subjects will be randomly assigned to 1 of the following 3 treatment groups in a 1:1:1 ratio:
- Group 1: Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks
- Group 2: Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks
- Group 3: Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks
Then subjects will undergo study procedures at Titration Visit (Visit 3 [Day 14]), Treatment Visit (Visit 4 Day 42]) and End-of-Treatment Visit (Visit 5 [Day 84]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: firibastat 100 mg | Experimental | Drug: FiribastatSubjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks. |
| Group 2: firibastat 500 mg | Experimental | Drug: FiribastatSubjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks. |
| Group 3: ramipril 5 mg | Active comparator | Drug: RamiprilSubjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1 V6).
- Primary PCI of the index-MI-related artery within 24 hours after the MI.
Key exclusion criteria (7 listed)
- Body mass index >45 kg/m².
- Subject is hemodynamically unstable or has cardiogenic shock.
- Subjects with clinical signs of HF (Kilipp III and IV).
- Systolic blood pressure <100 mmHg at inclusion visit
- Early primary PCI of the index-MI-related artery performed within 3 hours after MI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril1 or 2 capsules administered orally, twice daily | Drug | Group 3: ramipril 5 mg |
| FiribastatAlso: QGC0011 or 2 capsules administered orally, twice daily | Drug | Group 1: firibastat 100 mg, Group 2: firibastat 500 mg |
Primary outcome
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI)
Time frame: 84 days
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
4 secondary outcomes
Left-ventricle End-diastolic Volume Assessed by CMRI
Time frame: 84 days
Left-ventricle End-systolic Volume Assessed by CMRI
Time frame: 84 days
Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization
Time frame: 84 days
N-terminal Pro B-type Natriuretic Peptide (NT proBNP)
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36757536Montalescot G, Alexander JH, Cequier-Fillat A, Solomon SD, Redheuil A, Hudec M, Silvain J, Kachenoura N, Janas A, Orban M, Josse I, Balavoine F, Besse B. Firibastat Versus Ramipril After Acute Mechanical Reperfusion of Anterior Myocardial Infarction: A Phase 2 Study. Am J Cardiovasc Drugs. 2023 Mar;23(2):207-217. doi: 10.1007/s40256-023-00567-8. Epub 2023 Feb 9.
- Derived from this study: PubMed 33027067Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Montalescot, MD, PhD principal investigator
Groupe Hospitalier Pitié-Salpêtrière - Paris
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ramipril and Firibastat in people with Myocardial Infarction, run by Quantum Genomics SA at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany, Hungary, Poland, Slovakia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI) (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715998, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.