TY - JOUR T1 - Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial JF - Heart JO - Heart SP - 1593 LP - 1599 DO - 10.1136/heartjnl-2017-312774 VL - 104 IS - 19 AU - Thomas Engstrøm AU - Lars Nepper-Christensen AU - Steffen Helqvist AU - Lene Kløvgaard AU - Lene Holmvang AU - Erik Jørgensen AU - Frants Pedersen AU - Kari Saunamaki AU - Hans-Henrik Tilsted AU - Adam Steensberg AU - Søren Fabricius AU - Ulrik Mouritzen AU - Niels Vejlstrup AU - Kiril A Ahtarovski AU - Christoffer Göransson AU - Litten Bertelsen AU - Kasper Kyhl AU - Göran Olivecrona AU - Henning Kelbæk AU - Jens Flensted Lassen AU - Lars Køber AU - Jacob Lønborg Y1 - 2018/10/01 UR - http://heart.bmj.com/content/104/19/1593.abstract N2 - Objectives Reperfusion immediately after reopening of the infarct-related artery in ST-segment elevation myocardial infarction (STEMI) may cause myocardial damage in addition to the ischaemic insult (reperfusion injury). The gap junction modulating peptide danegaptide has in animal models reduced this injury. We evaluated the effect of danegaptide on myocardial salvage in patients with STEMI.Methods In addition to primary percutaneous coronary intervention in STEMI patients with thrombolysis in myocardial infarction flow 0–1, single vessel disease and ischaemia time less than 6 hours, we tested, in a clinical proof-of-concept study, the therapeutic potential of danegaptide at two-dose levels. Primary outcome was myocardial salvage evaluated by cardiac MRI after 3 months.Results From November 2013 to August 2015, a total of 585 patients were randomly enrolled in the trial. Imaging criteria were fulfilled for 79 (high dose), 80 (low dose) and 84 (placebo) patients eligible for the per-protocol analysis. Danegaptide did not affect the myocardial salvage index (danegaptide high (63.9±14.9), danegaptide low (65.6±15.6) and control (66.7±11.7), P=0.40), final infarct size (danegaptide high (19.6±11.4 g), danegaptide low (18.6±9.6 g) and control (21.4±15.0 g), P=0.88) or left ventricular ejection fraction (danegaptide high (53.9%±9.5%), danegaptide low (52.7%±10.3%) and control (52.1%±10.9%), P=0.64). There was no difference between groups with regard to clinical outcome.Conclusions Administration of danegaptide to patients with STEMI did not improve myocardial salvage.Trial registration number NCT01977755; Pre-results. ER -