PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
Megadott ok: The study was terminated early on 14th September 2023 by the main funding company because of financial futility. We were able to enroll 243 of the initial planned 360 participants and randomised 209 participants of the intial planned 286.
Key facts
- Where
- Singapore, SzingapúrSee the 6 sites
- Phase
- 2. fázis
Where in Szingapúr
- Changi General Hospital (CGH)Singapore, SzingapúrNo longer taking part
- Khoo Teck Puat Hospital (KTPH)Singapore, SzingapúrNo longer taking part
- National Heart Centre Singapore (NHCS)Singapore, SzingapúrNo longer taking part
- National University Heart Centre, Singapore (NUHCS)Singapore, SzingapúrNo longer taking part
- Ng Teng Fong General Hospital (NTFGH)Singapore, SzingapúrNo longer taking part
- Tan Tock Seng Hospital TTSHSingapore, SzingapúrNo longer taking part
Trial details
- Who runs it
- National University Heart Centre, Singapore
- Trial code
- NCT04601467
- Record updated
- 2025. április 27.
- Original description
This is a multi-center study conducted at 8 sites in 2 countries (Singapore, New Zealand). Patients with an acute myocardial infarction (AMI) were randomized in a ratio of 1:1 ratio to receive AZD5718 (Atuliflapon) 125 mg or placebo for 12 months to assess the efficacy of AZD5718 to prevent coronary plaque progression as measured on serial computer tomographic coronary angiography.Read full original descriptionShow less
This is a multi-center study conducted at 8 sites in 2 countries (Singapore, New Zealand). Patients with an acute myocardial infarction (AMI) were randomized in a ratio of 1:1 ratio to receive AZD5718 (Atuliflapon) 125 mg or placebo for 12 months to assess the efficacy of AZD5718 to prevent coronary plaque progression as measured on serial computer tomographic coronary angiography.
Inclusion: 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: Prior coronary artery bypass grafting (CABG); 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; Known history of drug or alcohol abuse within 5 years of screening; Any planned coronary revascularisation, valve surgery, or cardiac resynchronisation within 7 months after randomisation; 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; 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; History of QT prolongation associated with other medications that required discontinuation of that medication; Congenital long QT syndrome; 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); CABG planned within 12 months of admission; Systolic blood pressure persistently <90 mm Hg or HR<40 beats per minute at time of enrolment; Participated in another interventional clinical study with an investigational pharmaceutical product during the last 3 months; No severe asthma attack that require emergency treatment or hospitalisation in the past 6 months.