PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

Last updated: April 23, 2025
Sponsor: National University Heart Centre, Singapore
Overall Status: Terminated

Phase

2

Condition

Coronary Artery Disease

Myocardial Ischemia

Angina

Treatment

Placebo

AZD5718

Clinical Study ID

NCT04601467
2020/
  • Ages 21-80
  • All Genders

Study Summary

This is a multi-center study conducted at 8 sites in 2 countries (Singapore, New Zealand). Patients with an acute myocardial infarction (AMI) were randomized in a ratio of 1:1 ratio to receive AZD5718 (Atuliflapon) 125 mg or placebo for 12 months to assess the efficacy of AZD5718 to prevent coronary plaque progression as measured on serial computer tomographic coronary angiography.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • hospitalised for STEMI or non-STEMI, as defined by the 4th universal definition ofMI

  • underwent coronary angiography during the index hospitalisation showing at least oneepicardial coronary artery with ≥50% stenosis and a 2nd epicardial coronary arterywith ≥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

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 requireddiscontinuation of that medication

  • Congenital long QT syndrome

  • Systolic blood pressure persistently <90 mm Hg or HR<40 beats per minute at time ofenrolment

  • ALT >2 x ULN, cirrhosis, recent hepatitis, or positive screening test for hepatitisB (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 resynchronisationwithin 7 months after randomisation

  • Any concomitant medications known to be associated with Torsades de Pointes orpotent 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 investigationalpharmaceutical product during the last 3 months

  • Known hypersensitivity to drugs with a similar chemical structure or class of studydrugs or any of the excipients of the product

  • Known conditions that either increase the risk of performing the CT or make theprocedure technically impractical

  • No severe asthma attack that require emergency treatment or hospitalisation in thepast 6 months

  • Had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanicallyventilated), and/or had a confirmed case of COVID-19 within 4 weeks of ScreeningVisit

Study Design

Total Participants: 243
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 12, 2021
Estimated Completion Date:
August 14, 2024

Study Description

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 60 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.

Connect with a study center

  • North Shore Hospital

    Auckland,
    New Zealand

    Site Not Available

  • Christchurch Heart Institute (CHI)

    Christchurch,
    New Zealand

    Site Not Available

  • Changi General Hospital (CGH)

    Singapore,
    Singapore

    Site Not Available

  • Khoo Teck Puat Hospital (KTPH)

    Singapore,
    Singapore

    Site Not Available

  • National Heart Centre Singapore (NHCS)

    Singapore,
    Singapore

    Site Not Available

  • National University Heart Centre, Singapore (NUHCS)

    Singapore,
    Singapore

    Site Not Available

  • Ng Teng Fong General Hospital (NTFGH)

    Singapore,
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital (TTSH)

    Singapore,
    Singapore

    Site Not Available

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