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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04601467
Registration number
NCT04601467
Ethics application status
Date submitted
11/09/2020
Date registered
23/10/2020
Date last updated
15/12/2022
Titles & IDs
Public title
PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
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Scientific title
PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
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Secondary ID [1]
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2020/
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Universal Trial Number (UTN)
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Trial acronym
PASSIVATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD5718
Treatment: Drugs - Placebo
Experimental: AZD5718 - Patients will receive once daily oral dose of AZD5718 for 12 months
Placebo Comparator: Placebo - Patients will receive once daily oral dose of placebo matched to AZD5718 for 12 months
Treatment: Drugs: AZD5718
Oral dose of AZD5718 (tablet) once daily for 12 months
Treatment: Drugs: Placebo
Oral dose of matching placebo (tablet) once daily for 12 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in noncalcified coronary artery plaque volume (NCPV)
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Assessment method [1]
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Percent change in NCPV (in mm3), as assessed by CT coronary angiography, from baseline (before treatment) to after 12-month of treatment
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Timepoint [1]
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Baseline (before treatment) and after 12 months of treatment
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Secondary outcome [1]
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Change in CT pericoronary adipose tissue (PCAT)
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Assessment method [1]
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To assess whether AZD5718 reduces coronary inflammation
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Timepoint [1]
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Baseline (before treatment) and after 12 months of treatment
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Secondary outcome [2]
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Change in total plaque volume (mm3)
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Assessment method [2]
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Percent change in total plaque volume (in mm3), as assessed by CT coronary angiography, from baseline (before treatment) to after 12-month of treatment
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Timepoint [2]
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Baseline (before treatment) and after 12 months of treatment
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Secondary outcome [3]
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Echocardiographic assessment: Change in left ventricular ejection fraction (LVEF)
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Assessment method [3]
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Percent change in LVEF (%), as assessed by 2D echocardiography, from baseline (before treatment) to after 12-month of treatment
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Timepoint [3]
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Baseline (before treatment) and after 12 months of treatment
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Secondary outcome [4]
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Plasma concentrations of AZD5718
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Assessment method [4]
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To assess the PK of AZD5718 after repeated oral dosing for 12 months
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Timepoint [4]
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12 month
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Secondary outcome [5]
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Change in levels of urinary LTE4 (u-LTE4)
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Assessment method [5]
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To assess the pharmacodynamics (PD) effect of AZD5718 by assessment of u-LTE4 in AMI patients
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Timepoint [5]
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12 months
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Eligibility
Key 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
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Minimum age
21
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/07/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2024
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Actual
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Sample size
Target
360
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cairns Hospital - Cairns
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Recruitment hospital [2]
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Monash Medical Centre - Melbourne
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Recruitment postcode(s) [1]
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- Cairns
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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Singapore
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State/province [3]
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Singapore
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Funding & Sponsors
Primary sponsor type
Other
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Name
National University Heart Centre, Singapore
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AstraZeneca
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT04601467
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Trial related presentations / 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.
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.
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Public notes
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Contacts
Principal investigator
Name
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Mark Chan
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Address
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National University Heart Centre, Singapore
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sock Hwee Tan
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Address
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Country
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Phone
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+65 67795555
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04601467
Download to PDF