Newcastle Clinical Trials Unit



Evaluating the effectiveness of intravenous ciclosporin on reducing reperfusion injury in patients undergoing primary percutaneous coronary intervention: a double-blind, phase II, randomised controlled trial

Status: Closed
Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder: NIHR Biomedical Research Centre (BRC)
Therapeutic area: Cardiovascular
Type of study: CTIMP

Aim: To determine the effect of ciclosporin treatment prior to PPCI on infarct size at 12 weeks relative to placebo treatment.

Primary Outcome:  Infarct size at 12 weeks post-PPCI as measured by cardiac magnetic resonance imaging (MRI). Infarct size will be calculated as the percent of infarcted myocardium per LV mass.

• Clinical Phase: IIb
Population: Adult
Design: RCT
Setting: Emergency Care
Planned Sample Size: 68