Acute Coronary SyndromePhase 2PASSIVATENCT04601467

PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

A Phase 2 study testing AZD5718 in people with Acute Coronary Syndrome, run by National University Heart Centre, Singapore at 8 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: AZD5718
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 243 participants
Where: 8 sitesin 2 countries
Study dates: 12 Jul 2021to 14 Aug 2024
Phase: Phase 2
Are there results?: None posted in the registry

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 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

Singapore6 sites

Changi General Hospital (CGH)
Singapore
Khoo Teck Puat Hospital (KTPH)
Singapore
National Heart Centre Singapore (NHCS)
Singapore
National University Heart Centre, Singapore (NUHCS)
Singapore
Ng Teng Fong General Hospital (NTFGH)
Singapore
Tan Tock Seng Hospital (TTSH)
Singapore

Other trials in Singapore

New Zealand2 sites

North Shore Hospital
Auckland
Christchurch Heart Institute (CHI)
Christchurch

Other trials in New Zealand

About this study

Read the detailed 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.

Conditions: Acute Coronary Syndrome
Being tested: AZD5718, Placebo
Keywords: Acute Myocardial Infarction, Computed Tomography Coronary Angiography
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD5718Drug
Oral dose of AZD5718 (tablet) once daily for 12 months
PlaceboDrug
Oral dose of matching placebo (tablet) once daily for 12 months

Study groups in NCT04601467
Study group	Role	What they receive
AZD5718	Experimental	Patients will receive once daily oral dose of AZD5718 for 12 months Receives: Drug: AZD5718
Placebo	Placebo comparator	Patients will receive once daily oral dose of placebo matched to AZD5718 for 12 months Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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 treatment
Measured: Baseline (before treatment) and after 12 months of treatment

Secondary outcomes (4)

Change in CT peri vascular (coronary) adipose tissue (PVAT)
To assess whether AZD5718 reduces coronary inflammation
Measured: Baseline (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 treatment
Measured: Baseline (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 treatment
Measured: Baseline (before treatment) and after 12 months of treatment
Change in levels of urinary LTE4 (u-LTE4)
To assess the pharmacodynamics (PD) effect of AZD5718 by assessment of u-LTE4 in AMI patients
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 202114 Aug 2024

First posted23 Oct 2020
Study start12 Jul 2021
Primary completion27 May 2024
Study completion14 Aug 2024

Why it stopped: The study was terminated early on 14th September 2023 by the main funding company because of financial futility. We were able to enroll 243 of the initial planned 360 participants and randomised 209 participants of the intial planned 286.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04601467
Sponsor's protocol ID: 2020/
Acronym: PASSIVATE
Status last verified: Apr 2025
First submitted: 11 Sep 2020
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We will share anonmyised IPD upon reasonable request from academic investigators employed by universities and/or healthcare organisations to the study PIs.

Publications

Ericsson H, Nelander K, Lagerstrom-Fermer M, Balendran C, Bhat M, Chialda L, Gan LM, Heijer M, Kjaer M, Lambert J, Lindstedt EL, Forsberg GB, Whatling C, Skrtic S. Initial Clinical Experience with AZD5718, a Novel Once Daily Oral 5-Lipoxygenase Activating Protein Inhibitor. Clin Transl Sci. 2018 May;11(3):330-338. doi: 10.1111/cts.12546. Epub 2018 Mar 8.
PubMed 29517132
Pettersen D, Broddefalk J, Emtenas H, Hayes MA, Lemurell M, Swanson M, Ulander J, Whatling C, Amilon C, Ericsson H, Westin Eriksson A, Granberg K, Plowright AT, Shamovsky I, Dellsen A, Sundqvist M, Nagard M, Lindstedt EL. Discovery and Early Clinical Development of an Inhibitor of 5-Lipoxygenase Activating Protein (AZD5718) for Treatment of Coronary Artery Disease. J Med Chem. 2019 May 9;62(9):4312-4324. doi: 10.1021/acs.jmedchem.8b02004. Epub 2019 Mar 26.
PubMed 30869888

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
ClinicalTrials.gov ID: NCT04601467
Acronym / sponsor ID: PASSIVATE / 2020/
Conditions: Acute Coronary Syndrome
Keywords: Acute Myocardial Infarction, Computed Tomography Coronary Angiography
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated early on 14th September 2023 by the main funding company because of financial futility. We were able to enroll 243 of the initial planned 360 participants and randomised 209 participants of the intial planned 286.
Enrolment: 243 participants (actual)
Lead sponsor: National University Heart Centre, SingaporeUniversity, hospital or other
Collaborators: AstraZeneca, University of Otago
Study start: 12 Jul 2021 (actual)
Primary completion: 27 May 2024 (actual)
Study completion: 14 Aug 2024 (actual)
First posted: 23 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AZD5718	Experimental	Drug: AZD5718Patients will receive once daily oral dose of AZD5718 for 12 months
Placebo	Placebo comparator	Drug: PlaceboPatients will receive once daily oral dose of placebo matched to AZD5718 for 12 months

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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

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
AZD5718Oral dose of AZD5718 (tablet) once daily for 12 months	Drug	AZD5718
PlaceboOral dose of matching placebo (tablet) once daily for 12 months	Drug	Placebo

Primary outcome

Change in noncalcified coronary artery plaque volume (NCPV)
Time frame: Baseline (before treatment) and after 12 months of treatment
Percent change in NCPV (in mm3), as assessed by CT coronary angiography, from baseline (before treatment) to after 12-month of treatment

4 secondary outcomes

Change in CT peri vascular (coronary) adipose tissue (PVAT)
Time frame: Baseline (before treatment) and after 12 months of treatment
Change in total plaque volume (mm3)
Time frame: Baseline (before treatment) and after 12 months of treatment
Echocardiographic assessment: Change in left ventricular ejection fraction (LVEF)
Time frame: Baseline (before treatment) and after 12 months of treatment
Change in levels of urinary LTE4 (u-LTE4)
Time frame: 12 months

Results and safety

The study was stopped early (reason given: The study was terminated early on 14th September 2023 by the main funding company because of financial futility. We were able to enroll 243 of the initial planned 360 participants and randomised 209 participants of the intial planned 286.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Background: PubMed 29517132Ericsson H, Nelander K, Lagerstrom-Fermer M, Balendran C, Bhat M, Chialda L, Gan LM, Heijer M, Kjaer M, Lambert J, Lindstedt EL, Forsberg GB, Whatling C, Skrtic S. Initial Clinical Experience with AZD5718, a Novel Once Daily Oral 5-Lipoxygenase Activating Protein Inhibitor. Clin Transl Sci. 2018 May;11(3):330-338. doi: 10.1111/cts.12546. Epub 2018 Mar 8.
Background: PubMed 30869888Pettersen D, Broddefalk J, Emtenas H, Hayes MA, Lemurell M, Swanson M, Ulander J, Whatling C, Amilon C, Ericsson H, Westin Eriksson A, Granberg K, Plowright AT, Shamovsky I, Dellsen A, Sundqvist M, Nagard M, Lindstedt EL. Discovery and Early Clinical Development of an Inhibitor of 5-Lipoxygenase Activating Protein (AZD5718) for Treatment of Coronary Artery Disease. J Med Chem. 2019 May 9;62(9):4312-4324. doi: 10.1021/acs.jmedchem.8b02004. Epub 2019 Mar 26.
Individual participant dataSharing planned: Yes. We will share anonmyised IPD upon reasonable request from academic investigators employed by universities and/or healthcare organisations to the study PIs.

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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.

Mark Chan principal investigator

National University Heart Centre, Singapore

Derek Hausenloy principal investigator

National Heart Centre Singapore

A. Mark Richards study chair

National University Heart Centre, Singapore

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD5718 in people with Acute Coronary Syndrome, run by National University Heart Centre, Singapore at 8 sites in 2 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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Singapore, New Zealand. 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. Some participants in this study may receive a placebo. 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?

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?

Change in noncalcified coronary artery plaque volume (NCPV) (time frame: Baseline (before treatment) and after 12 months of treatment). 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 NCT04601467, 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 Apr 2025.