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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04601467




Registration number
NCT04601467
Ethics application status
Date submitted
11/09/2020
Date registered
23/10/2020

Titles & IDs
Public title
PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
Scientific title
PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
Secondary ID [1] 0 0
2020/
Universal Trial Number (UTN)
Trial acronym
PASSIVATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in noncalcified coronary artery plaque volume (NCPV)
Timepoint [1] 0 0
Baseline (before treatment) and after 12 months of treatment
Secondary outcome [1] 0 0
Change in CT pericoronary adipose tissue (PCAT)
Timepoint [1] 0 0
Baseline (before treatment) and after 12 months of treatment
Secondary outcome [2] 0 0
Change in total plaque volume (mm3)
Timepoint [2] 0 0
Baseline (before treatment) and after 12 months of treatment
Secondary outcome [3] 0 0
Echocardiographic assessment: Change in left ventricular ejection fraction (LVEF)
Timepoint [3] 0 0
Baseline (before treatment) and after 12 months of treatment
Secondary outcome [4] 0 0
Plasma concentrations of AZD5718
Timepoint [4] 0 0
12 month
Secondary outcome [5] 0 0
Change in levels of urinary LTE4 (u-LTE4)
Timepoint [5] 0 0
12 months

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
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cairns Hospital - Cairns
Recruitment hospital [2] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
National University Heart Centre, Singapore
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Chan
Address 0 0
National University Heart Centre, Singapore
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sock Hwee Tan
Address 0 0
Country 0 0
Phone 0 0
+65 67795555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04601467