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Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01977755
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Brief Summary:
This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.

Condition or disease Intervention/treatment Phase
Focus of Study is STEMI Drug: danegaptide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 591 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study Start Date : November 2013
Actual Primary Completion Date : December 20, 2015
Actual Study Completion Date : June 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: danegapetide high dose
7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours
Drug: danegaptide
Active Comparator: danegaptide low dose
2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours
Drug: danegaptide
Placebo Comparator: Placebo
bolus injection, followed by infused over 6 hours
Drug: Placebo



Primary Outcome Measures :
  1. Myocardial Salvage Index [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI [ Time Frame: 3 months ]
  2. Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure [ Time Frame: 60 minutes ]
  3. Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • ST-segment elevation myocardial infarction
  • Acute onset of chest pain of < 12 hours duration

Exclusion Criteria:

  • Pregnancy
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977755


Locations
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Denmark
The Heart Center, Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Zealand Pharma
Investigators
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Principal Investigator: Thomas Engstrom, MD, DMSci The Heart Center, Rigshopitalet University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT01977755    
Other Study ID Numbers: 13-031
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: January 2016
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases