E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028595 |
E.1.2 | Term | Myocardial infarct |
|
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 |
Myocardial infarction, coronary syndrome, revascularisation procedure on a coronary artery Revascularisation procedure on a peripheral artery Stroke Transient ischaemic cerebral attack documented on a neurological consult in hospital Amputation for ischemic event Sudden death from cardiovascular causes Deep-vein thrombosis, pulmonary thromboembolism |
|
E.2.2 | Secondary objectives of the trial |
Glycemia, Insulin, Homa Index (in diabetic patient: HBA1c) Total cholesterol and HDL Triglycerides Blood pressure Bone mass Quality of life |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both sexes 60-80 year old, admitted in hospital for acute coronary syndrome (unstable angina, acute myocardial infarction). No clinical evidence of heart failure (class 1 according to the classification of the New York Heart Association) |
|
E.4 | Principal exclusion criteria |
Hypercalcemia and / or hypercalciuria, nephrolithiasis, chronic renal failure (creatinine clearance <60 ml / min) Patients suffering from chronic diseases (onco-haematological, endocrinological, nutritional, rheumatic, COPD) which can affect bone metabolism Congestive heart failure NYHA ≥ 2 and / or cardiac arrhythmias Patients already in therapy with supplements of calcium and vitamin D Drugs which can affect calcium phosphoric metabolism: cortisone, l-thyroxine in soppressive dose, phenytoin, phenobarbital, chemotherapy drugs (type methotrexate or other antimetabolites), GnRH agonists, progesterone depot, aromatase inhibitors, lithium, antacids chelating phosphates, tetracycline, phenothiazine, cyclosporine, tacrolimus. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Myocardial infarction, coronary syndrome, revascularisation procedure on a coronary artery Revascularisation procedure on a peripheral artery Stroke Transient ischaemic cerebral attack documented on a neurological consult in hospital Amputation for ischemic event Sudden death from cardiovascular causes Deep-vein thrombosis, pulmonary thromboembolism |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |