Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial

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Fältnamn	Indikatorer	Metadata
000		05001naa a2200589 4500
001		oai:lup.lub.lu.se:d75dfdfd-10cc-4c8b-bc05-3ed7024bf587
003		SwePub
008		180717s2018 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://lup.lub.lu.se/record/d75dfdfd-10cc-4c8b-bc05-3ed7024bf5872 URI
024	7	a https://doi.org/10.1136/heartjnl-2017-3127742 DOI
040		a (SwePub)lu
041		a engb eng
042		9 SwePub
072	7	a art2 swepub-publicationtype
072	7	a ref2 swepub-contenttype
100	1	a Engstrøm, Thomasu Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,University of Copenhagen4 aut0 (Swepub:lu)th4331en
245	1 0	a Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial
264		c 2018-03-30
264	1	b BMJ,c 2018
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kardiologi0 (SwePub)302062 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cardiac and Cardiovascular Systems0 (SwePub)302062 hsv//eng
653		a acute myocardial infarction
653		a cardiac magnetic resonance (cmr) imaging
653		a percutaneous coronary intervention
700	1	a Nepper-Christensen, Larsu University of Copenhagen4 aut
700	1	a Helqvist, Steffenu University of Copenhagen4 aut
700	1	a Kløvgaard, Leneu University of Copenhagen4 aut
700	1	a Holmvang, Leneu University of Copenhagen4 aut
700	1	a Jørgensen, Eriku University of Copenhagen4 aut
700	1	a Pedersen, Frantsu University of Copenhagen4 aut
700	1	a Saunamaki, Kariu University of Copenhagen4 aut
700	1	a Tilsted, Hans Henriku University of Copenhagen4 aut
700	1	a Steensberg, Adamu Zealand Pharma A/S4 aut
700	1	a Fabricius, Sørenu Zealand Pharma A/S4 aut
700	1	a Mouritzen, Ulriku Zealand Pharma A/S4 aut
700	1	a Vejlstrup, Nielsu University of Copenhagen4 aut
700	1	a Ahtarovski, Kiril A.u University of Copenhagen4 aut
700	1	a Göransson, Christofferu University of Copenhagen4 aut
700	1	a Bertelsen, Littenu University of Copenhagen4 aut
700	1	a Kyhl, Kasperu University of Copenhagen4 aut
700	1	a Olivecrona, Göranu Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine4 aut0 (Swepub:lu)kard-gol
700	1	a Kelbæk, Henningu Zealand University Hospital4 aut
700	1	a Lassen, Jens Flenstedu University of Copenhagen4 aut
700	1	a Køber, Larsu University of Copenhagen4 aut
700	1	a Lønborg, Jacobu University of Copenhagen4 aut
710	2	a Kardiologib Sektion II4 org
773	0	t Heartd : BMJg 104:19, s. 1593-1599q 104:19<1593-1599x 1355-6037x 1468-201X
856	4	u http://dx.doi.org/10.1136/heartjnl-2017-312774y FULLTEXT
856	4	u https://heart.bmj.com/content/heartjnl/104/19/1593.full.pdf
856	4 8	u https://lup.lub.lu.se/record/d75dfdfd-10cc-4c8b-bc05-3ed7024bf587
856	4 8	u https://doi.org/10.1136/heartjnl-2017-312774

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