E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic ischemic cardiopathy |
Cardiopatia ischemica cronica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic ischemic cardiopathy |
Cardiopatia ischemica cronica |
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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 | LLT |
E.1.2 | Classification code | 10032060 |
E.1.2 | Term | Other forms of chronic ischemic heart disease |
E.1.2 | System Organ Class | 100000004849 |
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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 |
Evaluate if treatment with of 75 mg of acetylsalicylic acid + 200 mg of n-3 fatty acids (omega 3 + ASA) is able to inhibit platelet COX-1 in vivo, in a similar way as the treatment with 100 mg acetylsalicylic acid (non inferiority limit of 6.7%). |
Valutare se un trattamento con 75 mg ASA + 200 mg omega-3 ¿ in grado di inibire la COX-1 piastrinica in vivo con un¿efficacia (effetto antipiastrinico) paragonabile a quella con ASA 100mg (limite di non inferiorit¿ del 6.7%) |
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E.2.2 | Secondary objectives of the trial |
Evaluation of tolerability (pro-haemorragic effect and "coronary instability" of treatments. Evaluation of the efficacy (anti-platelet effect) on platelet COX 1 inhibition ex vivo |
Valutare la tollerabilit¿ (effetto pro-emorragico e possibilit¿ di comparsa di ¿instabilit¿ coronarica¿) dei trattamenti. Valutare l¿efficacia (effetto antipiastrinico) dei trattamenti nell¿inibire la COX-1 piastrinica ex vivo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with stable coronary heart disease, aged between 18 and 80 years, already treatrd with ASA 100 mg for at least one month.
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Pazienti con coronaropatia stabile, di età compresa tra i 18 e gli 80 anni, già in trattamento con ASA 100 mg da almeno 1 mese.
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E.4 | Principal exclusion criteria |
The exclusion criteria are: a percutaneous angioplasty or acute coronary syndrome in the month prior to randomization; treatment with inhibitors of glycoprotein IIb / IIIa or thrombolytics agents in the month prior to randomization; concomitant treatment with products containing fatty acids of the n-3 series; concomitant treatment with ibuprofen, naproxen, or warfarin; thrombocytopenia (platelet count =100x103 cells / mm3); anemia (hemoglobin =10 g / dl); renal impairment (creatinine 2.5 mg / dl). |
I criteri di esclusione sono: una angioplastica percutanea o una sindrome coronarica acuta nel mese precedente la randomizzazione; trattamento con inibitori della glicoproteina IIb / IIIa o agenti trombolitici nel mese precedente la randomizzazione; trattamento concomitante con prodotti contenenti acidi grassi della serie n-3; trattamento concomitante con ibuprofene, naprossene, o warfarin ; trombocitopenia (numero di piastrine =100x103 cellule/mm3); anemia (emoglobina =10 g/dl ); insufficienza renale (creatinina 2,5 mg/dl) . |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluate the efficacy (antiplatelet effect) of Cardioral (75 mg ASA + 200 mg omega-3) in inhibiting platelet COX-1 |
Valutare l’efficacia (effetto antipiastrinico) di Cardioral (75 mg ASA + 200 mg omega-3) nell’inibire la COX-1 piastrinica |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
before treatment and afterwards on days 1, 7, 36, 60 e 90 of treatment |
prima dell'inizio del trattamento e poi nei giorni 1, 7, 36, 60 e 90 di trattamento |
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E.5.2 | Secondary end point(s) |
monitoring for haemorragic effects or coronary instability |
rilevazione di eventuali eventi emorragici o di instabilit¿ coronarica |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
during the whole duration of the study and in particular on days 1, 7, 36, 60 e 90 of treatment |
per tutta la durata dello studio ed in particolare nei giorni 1, 7, 36, 60 e 90 di trattamento |
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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 | No |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| 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.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |