PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Heart Centre, Singapore
• Collaborator: AstraZeneca

Criteria

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