The PASSIVATE Study
Research type
Research Study
Full title
PASSIvation of Vulnerable plaque with AZD5718 in AcuTe coronary syndromE
IRAS ID
298755
Contact name
David Newby
Contact email
Sponsor organisation
NATIONAL UNIVERSITY HOSPITAL (SINGAPORE) PTE LTD
Eudract number
2021-001719-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U111-1260-0170, Universal Trial Number (UTN)
Duration of Study in the UK
2 years, 6 months, 29 days
Research summary
PASSIVATE is a multi-centre, randomised, double-blind, placebo-controlled Phase IIa trial which will be conducted at 14 sites in 3 countries (Singapore, New Zealand and United Kingdom). Approximately 120 patients from each country suffering with heart attacks will be randomly given a placebo tablet or AZD5718 125mg. Treatment duration will be for 12 months, once daily in the morning, to be taken with approximately 250ml of water and no restrictions on food intake.
The main question being asked in PASSIVATE is whether 12 months of treatment with AZD5718, an inhibitor with antiinflammatory properties, reduces the progression of coronary disease. This will be measured on serial computed tomography coronary angiography (CTCA) studies performed at baseline and after 12 months of therapy. These heart scans allow us to measure how much furring there is in the arteries of the heart, and therefore detect the change in ammount of furring over the year. During the 12 month period patients will be closely monitored with regular blood tests, ECGs and questionnaires.
Study medication will be given in addition to standard care.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0549
Date of REC Opinion
7 Sep 2021
REC opinion
Further Information Favourable Opinion