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

Phase 2

Completed

• Conditions: Focus of Study is STEMI
• Interventions: Drug: Placebo; Drug: danegaptide

• Registration Number: NCT01977755
• Lead Sponsor: Zealand Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study Start: 2013-11
• Study First Posted: 2013-11-07
• Primary Completion: 2015-12-20
• Status Verified: 2016-01
• Study Completion: 2016-06-08
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	bolus injection, followed by infused over 6 hours
danegapetide high dose	danegaptide	7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours
danegaptide low dose	danegaptide	2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours

Primary Outcome Measures

Name	Time	Method
Myocardial Salvage Index	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

Name	Time	Method
Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI	3 months
Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure	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

Trial Locations

Locations (1)

The Heart Center, Rigshospitalet, University of Copenhagen; 🇩🇰 Copenhagen, Denmark