PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE (PASSIVATE)

PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE (PASSIVATE)

Brief 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.

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 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: PASSIvation of Vulnerable Plaque With AZD5718 in AcuTe Coronary syndromE
Estimated Study Start Date: January 1, 2021
Estimated Primary Completion Date: April 30, 2023
Estimated Study Completion Date: September 30, 2023

Arm:
- Experimental: AZD5718
- Placebo Comparator: Placebo

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