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

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ClinicalTrials.gov Identifier: NCT03715998
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Quantum Genomics SA

Brief 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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Ramipril Drug: Firibastat Phase 2

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]).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: Group 1: firibastat 50 mg
Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks.
Drug: Firibastat
1 or 2 capsules administered orally, twice daily
Other Name: QGC001

Experimental: Group 2: firibastat 250 mg
Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks.
Drug: Firibastat
1 or 2 capsules administered orally, twice daily
Other Name: QGC001

Active Comparator: Group 3: ramipril 2.5 mg
Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks.
Drug: Ramipril
1 or 2 capsules administered orally, twice daily




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Left-ventricle end-diastolic volume assessed by CMRI [ Time Frame: 84 days ]
    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

  2. Left-ventricle end-systolic volume assessed by CMRI [ Time Frame: 84 days ]
    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

  3. Major cardiac event (MACE): combined clinical endpoint of cardiovascular death, MI, and cardiac hospitalization [ Time Frame: 84 days ]
    Comparison of the effects of BID administration of firibastat and ramipril on major cardiac event (MACE) over 84 days

  4. N-terminal pro b-type natriuretic peptide (NT proBNP) [ Time Frame: 84 days ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715998


Contacts
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Contact: Bruno Besse, MD +33 1 85 34 77 70 bruno.besse@quantum-genomics.com
Contact: Mariette Codou, PharmD +33 (0)1 85 34 77 74 mariette.codou@quantum-genomics.com

Locations
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France
Groupe Hospitalier Pitie-Salpêtrière - Institut de Cardiologie Recruiting
Paris, France, 75013
Contact: Gilles Montalescot    +33 1 42 16 29 59      
Germany
UKSH Kiel Active, not recruiting
Kiel, Germany
Hungary
Central Hospital of Hungarian Army Recruiting
Budapest, Hungary
Contact: Robert KISS, MD         
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II Recruiting
Kraków, Poland
Contact: Jacek Legutko         
Slovakia
NUSCH Bratislava Dpt. of Acute Cardiology Recruiting
Bratislava, Slovakia
Contact: Marek ORBAN, MD         
Spain
Hospital La Paz, Recruiting
Madrid, Spain
Contact: Isabel Antorrena, MD         
United Kingdom
Freeman Hospital Newcastle upon Tyne Recruiting
Newcastle, United Kingdom
Contact: Ian PURCELL, MD         
Sponsors and Collaborators
Quantum Genomics SA
Investigators
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Principal Investigator: Gilles Montalescot, MD, PhD Groupe Hospitalier Pitié-Salpêtrière - Paris
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Responsible Party: Quantum Genomics SA
ClinicalTrials.gov Identifier: NCT03715998    
Other Study ID Numbers: QGC001-2QG4
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ramipril
Firibastat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents