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

Focus of Study is STEMI Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977755
• Other study ID #: 13-031
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2013
• Last updated: April 5, 2018
• Start date: November 2013
• Est. completion date: June 8, 2016

Study information

• Verified date: January 2016
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 591
• Est. completion date: June 8, 2016
• Est. primary completion date: December 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Focus of Study is STEMI
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• danegaptide

• Placebo

Locations

Country	Name	City	State
Denmark	The Heart Center, Rigshospitalet, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Zealand Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI		3 months
Secondary	Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure		60 minutes
Secondary	Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure		3 months