E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH ACS TREATED WITH coronary angioplasty |
PAZIENTI CON SINDROME CORONARICA ACUTA TRATTATI CON ANGIOPLASTICA CORONARICA |
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E.1.1.1 | Medical condition in easily understood language |
Patients with unstable angina or myocardial infarction TREATED WITH CORONARY ANGIOPLASTY |
PAZIENTE CON ANGINA INSTABILE O INFARTO MIOCARDICO TRATTATI CON ANGIOPLASTICA CORONARICA |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
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 |
The purpose of the ARMYDA-RELOAD ACS is to examine whether in patients with NSTE-ACS already receiving chronic clopidogrel, a further loading dose of 600 mg administered before coronary angioplasty procedure might provide protection from cardiac ischemic complications with respect to dose standard 75 mg / day of clopidogrel. |
Scopo del ARMYDA RELOAD-ACS è quindi valutare se in pazienti con NSTE-ACS già in terapia cronica con clopidogrel, un’ulteriore dose di carico di 600 mg somministrata prima della procedura di angioplastica coronarica possa conferire una protezione dalle complicanze ischemiche cardiache rispetto alla dose convenzionale di 75 mg/die di clopidogrel. |
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E.2.2 | Secondary objectives of the trial |
ANTIPLATELET EFFICACY OF A FURTHER CLOPIDOGREL RELOAD |
EFFICACIA ANTIAGGREGANTE DI UN RICARICO DI CLOPIDOGREL |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Unstable angina or myocardial infarction without ST-segment ELEVATION |
Angina instabile o infarto miocardico senza sovraslivellamento del tratto ST |
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E.4 | Principal exclusion criteria |
1. Patients undergoing primary coronary angioplasty for myocardial infarction with ST-segment sovraslivellamento 2. Patients with platelet counts below 70 × 109 / L 3. Patients undergoing surgery for coronary artery bypass graft in the previous three months 4. Patients with a recent episode of major bleeding (<6 months) |
1. Pazienti da sottoporre ad angioplastica coronarica primaria per infarto miocardico con sovraslivellamento del tratto ST 2. Pazienti con conta piastrinica inferiore a 70 × 109/L 3. Pazienti sottoposti ad intervento di by-pass aorto-coronarico nei precedenti tre mesi 4. Pazienti con recente episodio di sanguinamento maggiore (< 6 mesi) |
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E.5 End points |
E.5.1 | Primary end point(s) |
30-day incidence of major adverse cardiac events (death, myocardial infarction or TARGET VESSEL revascularization) |
Incidenza a 30 giorni dall’angioplastica coronarica di eventi cardiaci avversi maggiori (morte, infarto miocardico o nuova rivascolarizzazione del vaso “target”), sia nei pazienti arruolati nel registro che in quelli randomizzati. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Evaluation of peri-procedural residual platelet reactivity, incidence of bleeding complications |
Valutazione peri-procedurale della reattività piastrinica residua; Incidenza di complicanze emorragiche |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |