Save

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.

Simpliy with AI

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.

Simplify with AI

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

Simplify with AI

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

TREATMENT

Phase

PHASE2

Trial ID

NCT04601467

Intervention or treatment

DRUG: AZD5718

DRUG: Placebo

Conditions

• Acute Coronary Syndrome

Image related to Acute Coronary Syndrome

Condition: Acute Coronary Syndrome
DRUG: AZD5718 and other drugs
Cairns, Not Specified, Australia and more
Sponsor: National University Heart Centre, Singapore

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary 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 treatment	Baseline (before treatment) and after 12 months of treatment

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in CT pericoronary adipose tissue (PCAT)	To assess whether AZD5718 reduces coronary inflammation	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	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	Baseline (before treatment) and after 12 months of treatment
Plasma concentrations of AZD5718	To assess the PK of AZD5718 after repeated oral dosing for 12 months	12 month
Change in levels of urinary LTE4 (u-LTE4)	To assess the pharmacodynamics (PD) effect of AZD5718 by assessment of u-LTE4 in AMI patients	12 months

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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