Precision medicine with zibotentan in microvascular angina (PRIZE)
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, cross-over trial of zibotentan in microvascular angina
IRAS ID
257719
Contact name
Travers Maureen
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Eudract number
2018-004393-10
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Microvascular angina (MVA) is caused by abnormalities of the small vessels in the heart. Endothelin is a small chemical that circulates and accumulates in the blood vessel walls in patients with MVA, causing them to narrow or go into spasm and thicken in the longer term especially as levels of endothelin increase. As a result, patients experience pain, psychological burden and an inability to carry out daily activities.
Originally developed by AstraZeneca for prostate cancer, prior research has confirmed that Zibotentan relaxes the small blood vessels of patients with MVA which lends support to the idea that Zibotentan may bring some benefits to patients with MVA. This trial therefore proposes to look into repurposing zibotentan as a new treatment for patients with MVA. The primary objective is to assess the effect of add-on treatment with Zibotentan to treadmill exercise times in adult patients with MVA and impaired exercise intolerance. Zibotentan could provide a new treatment pathway for patients, as well as be made available to the NHS at substantially lower cost than the currently used medications.
The trial aims to initially invite approx. 356 participants for genetic testing. A minimum of 75-100 participants will go forward into the main study, receiving either 10mg zibotentan or a dummy matched tablet (placebo) daily over two 12 weeks periods of each, completing their final visit at week 34. The study assessments will involve a health check at each visit, including information on the patient’s wellbeing, genetic/research/safety bloods and a urine test, some quality of life questionnaires, and an exercise test. Participants will also have the option to consent to additional sub-study cardiovascular MRI scanning. Finally, participants will be invited to provide consent for long-term follow-up (maximum 20 years) of their electronic medical records (no additional patient contact).
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0110
Date of REC Opinion
3 Jun 2019
REC opinion
Further Information Favourable Opinion