PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
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 United Kingdom). Approximately 360 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.
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.
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 ≤35 kg/m2

 -  White Blood Cell count ≥ 8.2 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