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

Primary Purpose

Focus of Study is STEMI

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
danegaptide
Placebo
Sponsored by
Zealand Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focus of Study is STEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Heart Center, Rigshospitalet, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

danegapetide high dose

danegaptide low dose

Placebo

Arm Description

7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours

2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours

bolus injection, followed by infused over 6 hours

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2013
Last Updated
April 5, 2018
Sponsor
Zealand Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01977755
Brief Title
Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 20, 2015 (Actual)
Study Completion Date
June 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus of Study is STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
591 (Actual)

8. Arms, Groups, and Interventions

Arm Title
danegapetide high dose
Arm Type
Active Comparator
Arm Description
7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours
Arm Title
danegaptide low dose
Arm Type
Active Comparator
Arm Description
2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
bolus injection, followed by infused over 6 hours
Intervention Type
Drug
Intervention Name(s)
danegaptide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Myocardial Salvage Index
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI
Time Frame
3 months
Title
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
Title
Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Engstrom, MD, DMSci
Organizational Affiliation
The Heart Center, Rigshopitalet University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Center, Rigshospitalet, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29602883
Citation
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.
Results Reference
derived

Learn more about this trial

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

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