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PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
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
| DRUG: AZD5718
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
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
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