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OpenTrials
Completed

NCT Number: NCT01977755

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

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

Completed

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Key information

Conditions

Focus of Study is STEMI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

danegaptide

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 7, 2013
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.