A Clinical Trial Investigating the Effectiveness and Safety of a New Drug, Danegaptide, in Reducing Cardiac Muscle Damage after Treating an Acute Blood Cloth in the Heart with Balloon Dilatation.

• Conditions: The treatment of acute myocardial infarction, AMI is aimed at enabling the return of blood flow to the ischemic myocardium, thereby limiting the size of the infarct. However the reperfusion by itself causes additional damage to the myocardium. Reducing the size of the myocardial infarct can minimize the risk of heart failure and death.; MedDRA version: 16.1Level: PTClassification code 10063837Term: Reperfusion injurySystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 16.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002312-27-DK
• Lead Sponsor: Zealand Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-13
• Last Update Posted: 21 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients will be entered into this trial only if they meet all of the following criteria:
1. Men or women of minimum 18 years of age
2. STEMI as characterized by one of following:
a. minimum 2 mV ST-segment elevation in 2 or more leads (V1 through V4)
b. presumed new left bundle branch block with minimum of 1 mV concordant ST segment elevation
c. minimum 1 mV ST-segment elevation in 2 or more limb leads (II, III and aVF, I, aVL)
d. minimum 1mV ST segment elevation in 2 or more leads (V4-V6)
3. Clinical ischemic symptoms consistent with acute myocardial infarction (MI) for a maximum of 12 hours prior to percutaneous coronary intervention (PCI)
4. Women of childbearing potential must during the past 3 months have used an acceptable method of contraception to avoid pregnancy (hormonal contraceptives, intrauterine device or double barrier method (male condom plus diaphragm) and agree to use it throughout the study or practice sexual abstinence.
Note: A woman of childbearing potential is defined as any female:
a. who is not postmenopausal (defined as women over the age of 50 who have been amenorrheic for at least 12 consecutive months)
b. who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy)
5. Willingness and ability to provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Current participation or participation within the past 30 days in any other investigational study
2. Women who are pregnant or breastfeeding or who plan on becoming pregnant during the study
3. Known prior MI in same area as present STEMI, known conclusive hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
4. More than 12 hours between the onset of symptoms of acute MI and anticipated revascularization
5. Anticipated requirement, as assessed prior to randomization, for a staged treatment of coronary artery disease or other interventional or surgical procedures to treat heart disease (e.g., valve replacement, PCI, or coronary artery bypass graft) planned or scheduled to take place within 6 months after the investigational agent infusion
6. Receipt of any thrombolytic agent since onset of acute MI symptoms
7. Cardiogenic shock or hemodynamic instability within 24 hours prior to randomization, except brief VF that has been successfully cardioverted
8. Prior PCI or CABG of same coronary artery as present STEMI
9. Known contraindication to cardiac magnetic resonance imaging (MRI) such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] less than 30 mL/min/1.73 m2), presence of MRI contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), imbedded metal objects (e.g. shrapnel), or any other contraindication for cardiac MRI
10. Known active malignancy with an expected life-expectancy of less than 2 years
11. Previous enrolment in this study
12. Any concurrent condition, which, in the opinion of the investigator, would make the patient unsuitable for participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified