valvular aortic stenosis submitted to TAVI MedDRA version: 20.0 Level: PT Classification code 10002918 Term: Aortic valve stenosis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: CARDIRENE - 75 MG POLVERE PER SOLUZIONE ORALE 30 BUSTINE
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: LISINA ACETILSALICILATO
Current Sponsor code: ASA
Other descript
Sponsors
AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients undergoing an effective and uncomplicated procedure. Effective TAVI intervention means the correct positioning of a single aortic prosthesis in the appropriate anatomic site, with a residual gradient 18 years 3) Obtaining 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 462 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: 1) Need of anticoagulant therapy; 2) Medicated stent implant within 12 months prior to randomization; 3) Note or suspected hypersensitivity to ASA or clopidogrel; 4) Women of childbearing age; 5) Participation in another study protocol; 6) Ejection fraction <20%; 7) Acute coronary syndrome within the year preceding randomization; 8) Major bleeding event within 5 years from randomization; 9) Hemoglobin levels lower than 8 mg / dl; 10) History of asthma induced by administration of acetylsalicylates; 11) Evidence of gastric ulcer, duodenal or esophageal ulcer with active bleeding or clinically significant gastrointestinal bleeding within 8 weeks prior to randomization; 12) Any constitutional or acquired haemorrhagic disease; 13) Impaired renal function defined by eGFR values ¿¿<30 mL / min / 1.73 m2; 14) Hepatic pathology defined by serum ALT (SGPT), AST (SGOT), or alkaline phosphatase levels higher than 3 times the upper limit of normality; 15) Concomitant treatment with methotrexate at doses of 15 mg / week or more; 16) Pre-existing mastocytosis, in patients in whom the use of acetylsalicylic acid can induce serious hypersensitivity reactions; 17) Documented or suspected active malignant neoplasia or previous history, within 2 years prior to randomization; 18) Patients who must or want to continue taking illicit drugs or drugs that can interfere with the proper conduct of the study; 19) Chronic abuse of alcohol or drugs or any condition that in the judgment of the investigator doctor makes an unreliable subject in correctly completing the procedures of the study; 20) Any other clinical condition that would endanger the safety of patients in participating in the study or that could prevent the subjects from adhering to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine whether ASA 75 mg / day is superior to ASA 75 mg / day + clopidogrel 75 mg / day for 6 months for the primary endpoint specified below.;Secondary Objective: The secondary objective of the study is the evaluation of non-inferiority of ASA versus ASA + clopidogrel for risk of death, stroke / systemic embolism, rehospitalization due to clinical deterioration due to thrombotic dysfunction of the prosthesis. Other secondary objectives of the study are the evaluation of other secondary endpoints specified below.;Primary end point(s): L’endpoint primario dello studio è il composito di morte, stroke/embolismo sistemico, riospedalizzazione per deterioramento clinico dovuto a disfunzione trombotica della protesi, o sanguinamenti tipo 2, 3, 5 secondo la definizione del Bleeding Academic research Consortium (BARC) a 6 mesi dalla randomizzazione. La definizione del sanguinamento secondo i criteri BARC è riportata nella Tabella 1 sottostante insieme con le definizioni degli altri endpoint dello studio secondo il consenso del Valve Academic Research Consortium (VARC). Per deterioramento clinico si intende la presenza di edema o congestione polmonare, scompenso cardiaco congestizio, angina non correlata a coronaropatia, sincope o altri sintomi di bassa portata cardiaca. Per disfunzione trombotica della protesi si intende la presenza di gradiente trans protesico medio > 20 mmHg o di insufficienza della protesi di grado severo dovuta a difetto di un lembo valvolare verosimilmente secondario a trombosi di protesi. La presenza di insufficienza aortica dovuta ad un rigurgito paravalvolare non è da considerare disfunzione di protesi ai fini dell’endpoint primario. Le differenze tra i due gruppi di trattamento riguardo l’endpoint primario saranno analizzate mediante analisi di Kaplan-Meier e con il log-rank test, come specificato più in dettaglio nei metodi statistici.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints of the study. In addition to the risk of death, stroke / systemic embolism, rehospitalization due to clinical deterioration due to thrombotic prosthesis dysfunction, other secondary endpoints of the study include: to. The individual components of the primary endpoint b. Cardiac death c. The incidence of TIA and the stroke and TIA composite d. The composite of death or stroke / systemic embolism is. The composite of death or rehospitalization due to clinical deterioration due to thrombotic prosthesis dysfunction f. The composite of death, peripheral stroke / embolism, rehospitalization due to clinical deterioration due to thrombotic prosthesis dysfunction, or type 3 or 5 bleeding according to the BARC definition g. Thrombotic prosthesis dysfunction in the absence of clinical deterioration These objectives will also be assessed at 1 year of follow-up by randomization.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactU.O. Cardiologia (Rapezzi)
AOU di Bologna Policlinico S.Orsola-Malpighi
Outcome results
None listed