Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction
NCT ID: NCT01977755
Last Updated: 2018-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
591 participants
INTERVENTIONAL
2013-11-30
2016-06-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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danegapetide high dose
7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours
danegaptide
danegaptide low dose
2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours
danegaptide
Placebo
bolus injection, followed by infused over 6 hours
Placebo
Interventions
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danegaptide
Placebo
Eligibility Criteria
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Inclusion Criteria
* ST-segment elevation myocardial infarction
* Acute onset of chest pain of \< 12 hours duration
Exclusion Criteria
* Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
* Contraindication for cardiac MRI
* Inability to understand information or provide informed consent
18 Years
ALL
No
Sponsors
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Zealand Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Engstrom, MD, DMSci
Role: PRINCIPAL_INVESTIGATOR
The Heart Center, Rigshopitalet University of Copenhagen
Locations
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The Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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13-031
Identifier Type: -
Identifier Source: org_study_id
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