NCT04601467

PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: National University Heart Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	AZD5718	Oral dose of AZD5718 (tablet) once daily for 12 months
DRUG	Placebo	Oral dose of matching placebo (tablet) once daily for 12 months

Timeline

• Start date: 2021-07-12
• Primary completion: 2024-05-27
• Completion: 2024-08-14
• First posted: 2020-10-23
• Last updated: 2025-04-27

Locations

8 sites across 2 countries: New Zealand, Singapore