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This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| danegapetide high dose | Active Comparator | 7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours |
|
| danegaptide low dose | Active Comparator | 2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours |
|
| Placebo | Placebo Comparator | bolus injection, followed by infused over 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danegaptide | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Salvage Index | Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at risk | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI | 3 months | |
| Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Engstrom, MD, DMSci | The Heart Center, Rigshopitalet University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Center, Rigshospitalet, University of Copenhagen | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36576342 | Derived | Thomsen AF, Bertelsen L, Jons C, Jabbari R, Lonborg J, Kyhl K, Goransson C, Nepper-Christensen L, Atharovski K, Ekstrom K, Tilsted HH, Pedersen F, Kober L, Engstrom T, Vejlstrup N, Jacobsen PK. Scar border zone mass and presence of border zone channels assessed with cardiac magnetic resonance imaging are associated with ventricular arrhythmia in patients with ST-segment elevation myocardial infarction. Europace. 2023 Mar 30;25(3):978-988. doi: 10.1093/europace/euac256. | |
| 29602883 |
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| ID | Term |
|---|---|
| C000619914 | danegaptide |
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| Drug |
|
| 60 minutes |
| Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure | 3 months |
| Derived |
| Engstrom T, Nepper-Christensen L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Tilsted HH, Steensberg A, Fabricius S, Mouritzen U, Vejlstrup N, Ahtarovski KA, Goransson C, Bertelsen L, Kyhl K, Olivecrona G, Kelbaek H, Lassen JF, Kober L, Lonborg J. Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial. Heart. 2018 Oct;104(19):1593-1599. doi: 10.1136/heartjnl-2017-312774. Epub 2018 Mar 30. |