An interventional study of good clinical practice and bundle group in Myocardial Ischemia, Hemorrhage and Quality of Life, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Supportive care
A single-center, randomized trial of admitted patients with ischemic heart disease receiving percutaneous coronary intervention and stent implantation will be conducted at University Hospital of Ferrara. Patients will be randomized to either the control (standard care) or the bundle group in which patients will receive counseling regarding dual antiplatelet therapy management, advantages and side effects, screening for depression or anxiety, standardized education. The primary endpoint will be the difference in the quality of life as assessed by EQ-5D questionnaire.
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 448 is above the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process
Behavioral: good clinical practice
patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)
Behavioral: bundle group
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
Also known as: standard of care
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
Also known as: counseling regarding dual antiplatelet therapy management
quality of life
quality of life assessment in each patient by EQ-5D questionnaire
Time frame: 1 month
emergency room admission
number of access to emergency room service for bleeding
Time frame: 1 month
general practitioner visit
number of access to general practitioner for bleeding
Time frame: 1 month
dyspnea occurrence
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
Time frame: 1 month
bleeding academic research consortium (BARC) 2-3
occurrence of BARC 2-3 complications
Time frame: 1 month
bleeding academic research consortium (BARC) 1
occurrence of BARC 1 complications
Time frame: 1 month
ischemic adverse events
cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke
Time frame: 1 year
all-cause mortality
occurrence of all-cause death
Time frame: 1 year
BARC 1-3
occurrence of BARC1-3 complications
Time frame: 1 year
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara