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.
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 60 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
243
North Shore Hospital
Auckland, New Zealand
Christchurch Heart Institute (CHI)
Christchurch, New Zealand
Changi General Hospital (CGH)
Singapore, Singapore
Khoo Teck Puat Hospital (KTPH)
Singapore, Singapore
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
Time frame: Baseline (before treatment) and after 12 months of treatment
Change in CT peri vascular (coronary) adipose tissue (PVAT)
To assess whether AZD5718 reduces coronary inflammation
Time frame: 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
Time frame: 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
Time frame: Baseline (before treatment) and after 12 months of treatment
Change in levels of urinary LTE4 (u-LTE4)
To assess the pharmacodynamics (PD) effect of AZD5718 by assessment of u-LTE4 in AMI patients
Time frame: 12 months
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National Heart Centre Singapore (NHCS)
Singapore, Singapore
National University Heart Centre, Singapore (NUHCS)
Singapore, Singapore
Ng Teng Fong General Hospital (NTFGH)
Singapore, Singapore
Tan Tock Seng Hospital (TTSH)
Singapore, Singapore