Newcastle Clinical Trials Unit

FRACTAL

FRACTAL

A phase IIa, randomized, 2-arm parallel-group, placebo-controlled, double-blind, multi-centre trial to evaluate safety, tolerability, anti-inflammatory and cardio- protective effects after intravenous and oral administration of KAND567 in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention.

Study stage: In follow-up
Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder: Kancera AB, Solna, Sweden
Therapeutic area: Cardiovascular
Type of study: CTIMP

Aim: To determine the safety and tolerability following intravenous and oral administration of KAND567 in ST-Elevation Myocardial Infarction (STEMI) patients undergoing PCI.

Primary Outcome:  The safety and tolerability of KAND567 relative to placebo will be assessed on the following:

 Occurrence of adverse events (AEs) during 3 months trial participation
 Changes in vital signs between baseline and 3 months
 Safety bloods including blood chemistry, haematology and urinalysis. See table 8.1. These are compared with baseline values.

Clinical Phase: IIa
Population: Adults
Design: Randomised Control Trial (RCT)
Setting: Emergency Care
Planned Sample Size: 60