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CompletedNCT03715998QUORUMUpdated Feb 27, 2023Results posted

Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction

A Phase 2 interventional study of Ramipril and Firibastat in Myocardial Infarction, sponsored by Quantum Genomics SA. Completed at 7 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Quantum Genomics SA · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
295
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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]).

02

Conditions studied

  • Myocardial Infarction
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 295 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Quantum Genomics SA is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
295 participants (actual)

Study arms

  • Experimental
    Group 1: firibastat 100 mg

    Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.

    Drug: Firibastat

  • Experimental
    Group 2: firibastat 500 mg

    Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.

    Drug: Firibastat

  • Active comparator
    Group 3: ramipril 5 mg

    Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.

    Drug: Ramipril

Interventions

  • DrugRamipril

    1 or 2 capsules administered orally, twice daily

  • DrugFiribastat

    1 or 2 capsules administered orally, twice daily

    Also known as: QGC001

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 84 days

Secondary outcomes

  1. 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

    Time frame: 84 days

  2. 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

    Time frame: 84 days

  3. 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

    Time frame: 84 days

  4. 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)

    Time frame: 84 days

07

Results

Posted Feb 27, 2023

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 2.5 mg
Started989998
Completed818088
Not completed171910

Outcome measures

PrimaryLeft 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

Time frame:
84 days
Reported as:
Mean · percentage of left ventricular volumes
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI)
percentage of left ventricular volumesGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI)5.6 ± 1.25.3 ± 1.15.7 ± 1.1
SecondaryLeft-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

Time frame:
84 days
Reported as:
Mean · mL
Left-ventricle End-diastolic Volume Assessed by CMRI
mLGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
Left-ventricle End-diastolic Volume Assessed by CMRI14.2 ± 4.512.7 ± 4.39.4 ± 4.4
SecondaryLeft-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

Time frame:
84 days
Reported as:
Mean · mL
Left-ventricle End-systolic Volume Assessed by CMRI
mLGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
Left-ventricle End-systolic Volume Assessed by CMRI-0.5 ± 3.3-0.4 ± 3.2-3.1 ± 3.2
SecondaryMajor 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

Time frame:
84 days
Reported as:
Number · Event
Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization
EventGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization1086
SecondaryN-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)

Time frame:
84 days
Reported as:
Mean · pg/ml
N-terminal Pro B-type Natriuretic Peptide (NT proBNP)
pg/mlGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
N-terminal Pro B-type Natriuretic Peptide (NT proBNP)-1618.7 ± 1381.7-1596.4 ± 2279.6-1735.6 ± 2326.5

Adverse events

Collected over Adverse events collected from the ICF signature to the end of the study.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Firibastat 100 mg2/98 (2%)11/98 (11.2%)43/98 (43.9%)
Group 2: Firibastat 500 mg1/98 (1%)18/98 (18.4%)54/98 (55.1%)
Group 3: Ramipril 5 mg1/98 (1%)10/98 (10.2%)54/98 (55.1%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
Chest pain or chest discomfort (non cardiac)General disorders1/981/983/98
COVID19Infections and infestations1/983/980/98
AnemiaBlood and lymphatic system disorders0/980/982/98
Cardiac failureCardiac disorders1/982/980/98
Coronary artery diseaseCardiac disorders2/981/980/98
Acute kidney injuryRenal and urinary disorders0/981/982/98
Myocardial InfarctionCardiac disorders1/980/981/98
Angina pectorisCardiac disorders0/981/980/98
Aortic valve incompetenceCardiac disorders1/980/980/98
Cardiac ArrestCardiac disorders0/980/981/98
Most frequent other events
Showing 10 of 34
Most frequent other events
EventGroup 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mg
RashSkin and subcutaneous tissue disorders0/988/983/98
COVID-19Infections and infestations3/984/986/98
Chest disconfortGeneral disorders0/980/985/98
Chest painGeneral disorders2/984/985/98
DiarrheaGastrointestinal disorders1/981/985/98
Coronary artery diseaseCardiac disorders3/983/984/98
HypertensionVascular disorders2/984/980/98
HypotensionVascular disorders4/981/981/98
ContusionInjury, poisoning and procedural complications2/981/984/98
Cardiac failureCardiac disorders2/982/983/98

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mgTotal
<=18 years0000
Between 18 and 65 years575762176
>=65 years15201853
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mgTotal
Female17182055
Male555960174
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Group 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mgTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(participants)Group 1: Firibastat 100 mgGroup 2: Firibastat 500 mgGroup 3: Ramipril 5 mgTotal
Hungary25202267
Poland26252374
United Kingdom1225
Slovakia21262370
France13141340
Germany43411
Spain891128
08

Study locations

7 sites
  • Groupe Hospitalier Pitie-Salpêtrière - Institut de Cardiologie
    Paris, 75013, France
  • UKSH Kiel
    Kiel, Germany
  • Central Hospital of Hungarian Army
    Budapest, Hungary
  • Krakowski Szpital Specjalistyczny im. Jana Pawła II
    Kraków, Poland
  • NUSCH Bratislava Dpt. of Acute Cardiology
    Bratislava, Slovakia
  • Hospital La Paz,
    Madrid, Spain
  • Freeman Hospital Newcastle upon Tyne
    Newcastle, United Kingdom
09

References and documents

Publications

  • Khosla 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 documents

  • Study protocol · Oct 10, 2019
  • Statistical analysis plan · Jul 20, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03715998
Lead sponsor
Quantum Genomics SA
Responsible party
Sponsor
First posted
Oct 23, 2018
Start date
Jun 4, 2019
Primary completion
Jul 8, 2021
Completion
Jul 8, 2021
Results posted
Feb 27, 2023
Last update
Feb 27, 2023

Study contacts

Gilles Montalescot, MD, PhD
principal investigator · Groupe Hospitalier Pitié-Salpêtrière - Paris

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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