Patients with anterior or anterolateral STEMI subjected to primary PCI. MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849
Conditions
Interventions
Product Name: T3 Solution for injection 10µg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LIOTHYRONINE SODIUM
CAS Number: 55-06-1
Concentration unit: µg/ml microgram(s)/millilit
Sponsors
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Anterior or Anterolateral STEMI diagnosed according to ESC guidelines •Referral to cardiac catheterization laboratory for Primary PCI with TIMI grade 2 or 3 flow •Presentation within 12 hours of symptom onset (chest pain, chest discomfort) •Male and female with Age >18 years old •Signed 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: •Treatment with amiodarone at the time of admission •Clinically significant chronic hepatic impairment (Child-Pugh Class B [moderate] or Class C [severe]) •Previous Acute Myocardial Infarction •Previous history of Thyroid disease •Treatment with T4, T3 or anti-thyroid drugs at the time of admission to hospital •Renal failure (GFR75 years old •Severe systemic disease (cancer, auto-immune etc) accompanied by reduced life expectancy 16% at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective will be the assessment of myocardial function by CMR after administration of liothyronine in patients with anterior or anterolateral STEMI.;Secondary Objective: Secondary objectives will be the assessment of myocardial remodeling, injury, scar formation, diastolic dysfunction and safety.;Primary end point(s): The main efficacy end-point will be LV ejection fraction assessed by CMR. The investigators wish to detect a minimum difference of 7 units in ejection fraction at 6 months between the groups (in favour of treatment group). This difference in response to treatment is considered clinically significant.;Timepoint(s) of evaluation of this end point: 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following safety criteria will be assessed: cardiac and non-cardiac death, myocardial infarction, stroke, acute pulmonary edema, decompensated heart failure, angina, coronary revascularization, hospital re-admissions, episodes of arrhythmias (paroxysmal supraventricular tachycardia, atrial fibrillation, sustained ventricular tachycardia).;Timepoint(s) of evaluation of this end point: 6 months. | — |
Countries
Greece
Contacts
Public ContactRegulatory Affairs department
Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Outcome results
None listed