E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
All patients enrolled in the study should be in good clinical conditions, being ST-elevation myocardial infarction the main pathology,, without evidence of clinical/hemodynamic instability. All patients enrolled should present - at admission or within 72 hours after hospital arrival - borderline/reduced plasma levels of triiodothyronine (fT3 <2.2 pg/mL or decrease in fT3 plasma levels major than 20% with respect to the admission levels). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10011085 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028596 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
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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 |
To investigate 1)the safety and feasibility of synthetic thyroid hormone replacement therapy with a triiodothyronine analogue (Liotir) in patients with STEMI both in the acute (in hospital period) and chronic phase (after hospital discharge) of coronary artery disease and its association with cardiac function and outcome; 2) the effects of thyroid hormone replacement therapy on clinical outcome in terms of major (cardiac and non cardiac death, reinfarction) and minor (recurrence of angina, coronary revascularization, and hospital re-admission) events. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effects of thyroid hormone therapy on: Infarct size, regional wall motion abnormalities, systolic and diastolic myocardial function; Neuroendocrine imbalance; Patients functional capacity, quality of life, cognitive and behavioural status |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients, all ethnic races, admitted to the Coronary Care Unit for chest pain and subsequently proven STEMI (ST Elevation Myocardial Infarction); Age between 30 to 70 years; Patients subjected to coronary revascularization through PTCA and stenting PTCA performed within 12 hours from the onset of symptoms Evidence of fT3 levels below the lower referral limit (<2.2 pg/mL for our laboratory) or decrease in fT3 plasma levels major than 20% with respect to the admission levels Signature of a written informed consent before randomization |
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E.4 | Principal exclusion criteria |
Previous myocardial infarction Previous evidence of compromised left ventricular function (Ejection Fraction< 40%) Hemodynamic instability, cardiogenic shock, decompensated heart failure (NYHA IV class) at admission Use of inotropic drugs Thyroid disease Patients assuming: TH replacemement therapy, anti-thyroid drugs, corticosteroids, amiodarone, oral anticoagulant therapy, oral contraceptives Patients presenting atrial fibrillation or with previous documentation of paroximal or persistent atrial fibrillation Pregnant or breast-feeding women Sever systemic diseases including: neoplasia, decompensated diabetes mellitus with glicosilated haemoglobin levels major than 9%, liver cirrhosis, chronic obstructive lung disease with moderate to severe respiratory impairment, chronic kidney failure with creatinine plasma levels major than 3 mg/dL Systemic inflammatory/ autoimmune disease Patients holding mechanical cardiac valves, pace-makers or infusion pumps, magnetic materials like metallic clips and prothesis Patients allergic to synthetic thyroid hormone or any eccipient in the drug eventually administered Patients refusing or unable to supply written informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the effects of TH replacement therapy in patients with STEMI and borderline/reduced fT3 plasma levels on outcome and major (cardiac and non cardiac death, reinfarction) and minor (angina, coronary revascularization, hospitalization) adverse cardiac events . |
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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 | Yes |
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 | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |