E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Myocardial Infarction |
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E.1.1.1 | Medical condition in easily understood language |
The purpose of this study is to evaluate the effect of Adenosine on the recovery of the heart muscle after a heart attack. |
Syftet med denna studie är att utvärdera effekten av Adenosin på hjärtmuskelns återhämtningsförmåga efter en hjärtinfarkt |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000930 |
E.1.2 | Term | Acute myocardial infarction, unspecified site, initial episode of care |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Study objectives: The objective of the study is to investigate whether treatment with adenosine hastens recovery of myocardial akinesia and improves cardiac function at 48 hours in patients with STEMI. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age ≥ 18 years. 2. A clinical diagnosis of anterior STEMI 3. Symptom duration ≤6 hours 4. Written informed consent obtained
Angiographic inclusion criteria a. Culprit lesion in LAD, major branch of LAD, proximal or mid LCx or proximal or mid RCA b. TIMI flow ≤2 in the culprit vessel Echocardiographic inclusion criteria c. Detectable hypo- or akinesia corresponding to ≥5% of the left ventricle corresponding to culprit lesion, per bedside visual assessment.
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E.4 | Principal exclusion criteria |
1. Previous randomization in the study 2. Any of the following contraindications for treatment with adenosine: a. Known pre-existing atrioventricular block grade ≥2 or sick sinus syndrome in patients without pacemaker. b. Known pre-existing elevation of intracranial pressure c. Treatment with dipyridamole within 24 hours of randomization d. Systolic blood pressure <80 mm Hg at screening 3. Any concomitant condition resulting in a life expectancy of less than one month 4. Previous myocardial infarction or other cardiac condition resulting in impaired regional or global systolic function without documented recovery of cardiac function 5. Heart transplant or left ventricular assist device recipient 6. Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis or characteristics that may interfere with adherence to the trial protocol 7. Pregnancy or woman of childbearing potential who is not sterilized or using a medically accepted form of contraception
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E.5 End points |
E.5.1 | Primary end point(s) |
The resolution of myocardial stunning at 48 hours (StunningRes48h). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 48 hours after acute myocardial Infarction |
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E.5.2 | Secondary end point(s) |
1. Infarct size at 6 months, as assessed by cardiac magnetic resonance imaging (magnetic resonance imaging). 2. Ejection fraction days 1, 2, 3, 7, 14, 30 and 6 months. 3. Any sustained ventricular tachycardia or fibrillation within 72 hours (safety endpoint; binary) 4. Any high-grade atrioventricular block or sinus arrest within 72 hours (safety endpoint; binary) 5. Implantation of cardiac assist device within 72 hours (binary) 6. Stroke within 6 months (binary) 7. All-cause mortality within 6 months 8. Heart failure rehospitalization within 6 months* 9. Worsening in-hospital heart failure ≥12 hours after PCI# 10. Composite of any worsening in-hospital heart failure ≥12 hours after PCI or heart failure rehospitalization within 6 months.
*Defined as re-admission to hospital after discharge, with a total length of admission ≥24 hours, documented worsening of heart failure signs or symptoms (e.g. worsening dyspnea, fatigue, edema/fluid overload, pulmonary venous distension or signs of pulmonary edema on X-ray), with administration of intravenous diuretic or inotropic drugs, ultrafiltration, non-invasive ventilation or mechanical assist device. #Defined as intensification of heart failure therapy due to worsening heart failure signs or symptoms (as above; including intravenous diuretic, inotropic or vasopressor drugs, non-invasive ventilation or mechanical assist device).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 1, 2, 3, 7, 14, 30 and /or 6 months after acute myocardial Infarction |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is defined as the time of follow up at 180 days ± 7 days for the last patient enrolled |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |