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PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

PHASE2RECRUITING

This is a multi-center study conducted at 13 sites in 3 countries (Singapore, New Zealand, and the Australia). Approximately 260 patients with an acute myocardial infarction (AMI) will be randomized in a ratio of 1:1 ratio to receive AZD5718 125 mg or placebo for 12 months.

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Study details:

PASSIVATE is a randomized, double-blind, placebo-controlled Phase IIa trial that investigates how 12 months of treatment with AZD5718 modifies coronary plaque volume. Patients with recent STEMI or NSTEMI will receive an additional oral dose of AZD5718 (or placebo) once daily to standard clinical care for 12 months. The primary hypothesis being tested in PASSIVATE is that 12 months of treatment with AZD5718 attenuates the progression of non-calcified plaque (NCP) volume on serial computed tomography coronary angiography (CTCA) studies.

Patients who gave consent (within 30 days after their index event) will undergo a CTCA scan and start treatment (AZD5718 or Placebo). The treatment duration will be 12 months. During the treatment period, patients will come to the clinic for follow-ups.

At 12 months (end treatment), the patients will undergo their 2nd CTCA scan. A follow-up visit will be performed 4 weeks after the last dose in order to ensure the safety and well-being of the patients.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • hospitalised for STEMI or non-STEMI, as defined by the 4th universal definition of MI
  • underwent coronary angiography during the index hospitalisation showing at least one epicardial coronary artery with ≥50% stenosis and a 2nd epicardial coronary artery with ≥20% stenosis on the coronary angiogram
  • Body Mass Index (BMI) ≥18 to ≤40 kg/m2
  • White Blood Cell count ≥ 7.0 X 103/uL during admission
  • Exclusion criteria

  • Prior coronary artery bypass grafting (CABG)
  • CABG planned within 12 months of admission
  • Known history of drug or alcohol abuse within 5 years of screening
  • History of QT prolongation associated with other medications that required discontinuation of that medication
  • Congenital long QT syndrome
  • Systolic blood pressure persistently <90 mm Hg or HR<40 beats per minute at time of enrolment
  • ALT >2 x ULN, cirrhosis, recent hepatitis, or positive screening test for hepatitis B (hepatitis B surface antigen) or other viral hepatitis
  • Uncontrolled Type 1 or Type 2 DM defined as HbA1c >10% or 74.9 mmol/mol (by IFCC)
  • Any planned coronary revascularisation, valve surgery, or cardiac resynchronisation within 7 months after randomisation
  • Any concomitant medications known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4)
  • Planned treatment with zileuton, leukotriene receptor antagonists (e.g., montelukast) during trial
  • Participated in another interventional clinical study with an investigational pharmaceutical product during the last 3 months
  • Known hypersensitivity to drugs with a similar chemical structure or class of study drugs or any of the excipients of the product
  • Known conditions that either increase the risk of performing the CT or make the procedure technically impractical
  • No severe asthma attack that require emergency treatment or hospitalisation in the past 6 months
  • Had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks of Screening Visit
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    Eligibility

    Age eligible for study : 21 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-07-12

    Primary completion: 2023-03-31

    Study completion finish: 2024-09-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT04601467

    Intervention or treatment

    DRUG: AZD5718

    DRUG: Placebo

    Conditions

    • Acute Coronary Syndrome

    Find a site

    Closest Location:

    Cairns Hospital

    Research sites nearby

    Select from list below to view details:

    • Cairns Hospital

      Cairns, Not Specified, Australia

    • Monash Medical Centre

      Melbourne, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: AZD5718
    • Patients will receive once daily oral dose of AZD5718 for 12 months
    DRUG: AZD5718
    • Oral dose of AZD5718 (tablet) once daily for 12 months
    PLACEBO_COMPARATOR: Placebo
    • Patients will receive once daily oral dose of placebo matched to AZD5718 for 12 months
    DRUG: Placebo
    • Oral dose of matching placebo (tablet) once daily for 12 months

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change in noncalcified coronary artery plaque volume (NCPV)Percent change in NCPV (in mm3), as assessed by CT coronary angiography, from baseline (before treatment) to after 12-month of treatmentBaseline (before treatment) and after 12 months of treatment

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Change in CT pericoronary adipose tissue (PCAT)To assess whether AZD5718 reduces coronary inflammationBaseline (before treatment) and after 12 months of treatment
    Change in total plaque volume (mm3)Percent change in total plaque volume (in mm3), as assessed by CT coronary angiography, from baseline (before treatment) to after 12-month of treatmentBaseline (before treatment) and after 12 months of treatment
    Echocardiographic assessment: Change in left ventricular ejection fraction (LVEF)Percent change in LVEF (%), as assessed by 2D echocardiography, from baseline (before treatment) to after 12-month of treatmentBaseline (before treatment) and after 12 months of treatment
    Plasma concentrations of AZD5718To assess the PK of AZD5718 after repeated oral dosing for 12 months12 month
    Change in levels of urinary LTE4 (u-LTE4)To assess the pharmacodynamics (PD) effect of AZD5718 by assessment of u-LTE4 in AMI patients12 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

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