Additional Information
for Healthcare Personnel
About the Study Medication
The study medication is a small-molecule TRPC ion channel inhibitor. The study medication works by blocking the activity of transient receptor potential channels (TRPC), specifically TRPC3, TRPC6, and TRPC7. These channels play a role in regulating the movement of molecules such as calcium across cell membranes, which is critical to various cellular processes. By inhibiting TRPC activity, the study medication may help prevent cellular mechanisms that lead to heart cell death, potentially offering protection during ischaemic reperfusion injury.
In a Phase 1 trial involving healthy volunteers, the study medication was administered as an intravenous infusion for up to six hours. The study demonstrated that the study medication was safe and well tolerated. Preclinical studies also showed strong efficacy in reducing cardiovascular damage caused by myocardial ischemia-reperfusion injury.
Additional Inclusion/exclusion criteria
Inclusion criteria
Main inclusion criteria includes male and female participants who are experiencing their first STEMI and are not of child-bearing potential.
Exclusion criteria
Main exclusion criteria includes: prior cardiac surgery, body weight less than 50 kg or greater than 120 kg, as well as any medical condition or abnormality that, in the opinion of the Investigator, would make study participation unsafe.
Study Schema
Day 1
Patient presents with STEMI
Informed consent obtained by Investigator
Investigator undertakes initial screen for eligibility
Eligibility confirmed: randomised and IP administration started
Coronary angiogram performed
PCI
ECG post PCI
Prior to Discharge
ECG and Echocardiogram
CMR (only for subset of patients)
Day 14 Phone call
Phone call safety follow up
Day 30 End of study visit
Echocardiogram, patient questionnaire, safety bloods and follow up