- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02554006
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings (BATMAN)
Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Recent studies suggest that bleeding complications have a strong influence on quality of life. During DAPT regimen bleeding complications occur from 5% to 15% of patients. Nuisance bleedings (BARC 1 bleeding) occur more frequently and show a strong influence on quality of life, depression, anxiety and compliance to the treatment.
The aim of the study is to establish if a specific counseling programme might minimize the negative quality of life impact of nuisance bleedings. A computer-generated list will be used to randomize patients in a 1:1 ratio, stratified by age, sex, renal failure and P2Y12 inhibitor, to either the bundle or the control group.
All patients randomized to the control group (standard of care) will receive education from physician regarding dual antiplatelet therapy (DAPT) as part of the routine discharge process.
All patients randomized to the bundle group will receive:
i) a 15-min visit by a member of the research team 24 h prior to the anticipated discharge day. During this visit, a core set of DAPT risks will be addressed. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
ii) a 15-min visit by a member of the research team with a family member living near/with the patient. Advantages and side effects of DAPT will be described. The importance of compliance will be discussed. The correct management of side effects (especially BARC 1 bleedings) will be discussed.
iii) brochure describing advantages, side effects and management of dual antiplatelet therapy. Contemporaneously, the investigators of the study will contact directly by phone and/or mail the general practionnaire of the patient to describe and explain the same topics and the clinical problem of her patient.
iv) availability of phone number to discuss potential side effects of DAPT. In addition, the study coordinator of the study will contact two times by month the patient by phone to assess DAPT compliance and potential BARC 1 bleedings.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ferrara
-
Cona, Ferrara, Italie, 44124
- University Hospital of Ferrara
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- signed written informed consent
- hospital admission for ischemic heart disease with clinical indication to coronary artery angiography
- percutaneous coronary intervention and drug eluting stent implantation
- indication to dual antiplatelet therapy for at least 6 months
Exclusion Criteria:
- oral anticoagulant therapy
- bleeding event in the 30 days before the enrolment
- planned surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Autre: good clinical practice
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
|
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
Autres noms:
|
Expérimental: bundle group
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
|
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
quality of life
Délai: 1 month
|
quality of life assessment in each patient by EQ-5D questionnaire
|
1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
emergency room admission
Délai: 1 month
|
number of access to emergency room service for bleeding
|
1 month
|
general practitioner visit
Délai: 1 month
|
number of access to general practitioner for bleeding
|
1 month
|
dyspnea occurrence
Délai: 1 month
|
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
|
1 month
|
bleeding academic research consortium (BARC) 2-3
Délai: 1 month
|
occurrence of BARC 2-3 complications
|
1 month
|
bleeding academic research consortium (BARC) 1
Délai: 1 month
|
occurrence of BARC 1 complications
|
1 month
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
ischemic adverse events
Délai: 1 year
|
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
|
1 year
|
all-cause mortality
Délai: 1 year
|
occurrence of all-cause death
|
1 year
|
BARC 1-3
Délai: 1 year
|
occurrence of BARC1-3 complications
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 150595
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