NCT01977755

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
591

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2016

Completed
Last Updated

April 6, 2018

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

October 30, 2013

Last Update Submit

April 5, 2018

Conditions

Focus of Study is STEMI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

    60 minutes

  • Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure

    3 months

Study Arms (3)

danegapetide high dose

ACTIVE COMPARATOR

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

Drug: danegaptide

danegaptide low dose

ACTIVE COMPARATOR

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

Drug: danegaptide

Placebo

PLACEBO COMPARATOR

bolus injection, followed by infused over 6 hours

Drug: Placebo

Interventions

danegaptideDRUG
danegapetide high dosedanegaptide low dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 36576342DERIVED

  • 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.

    PMID: 29602883DERIVED

MeSH Terms

Interventions

danegaptide

Study Officials

  • Thomas Engstrom, MD, DMSci

    The Heart Center, Rigshopitalet University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 7, 2013

Study Start

November 1, 2013

Primary Completion

December 20, 2015

Study Completion

June 8, 2016

Last Updated

April 6, 2018

Record last verified: 2016-01

Locations

DK(1)