Clinical trial NCT02554006: Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
Official title: Predischarge Bundle for Patients in Dual Antiplatelet Therapy to Minimize the Negative Impact of Nuisance Bleedings on Quality of Life: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Hemorrhage
Quality of Life
Platelet Aggregation Inhibitors
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: quality of life
timeFrame: 1 month
Secondary outcomes:
measure: emergency room admission
timeFrame: 1 month
measure: general practitioner visit
timeFrame: 1 month
measure: dyspnea occurrence
timeFrame: 1 month
measure: bleeding academic research consortium (BARC) 2-3
timeFrame: 1 month
measure: bleeding academic research consortium (BARC) 1
timeFrame: 1 month
Other outcomes:
measure: ischemic adverse events
timeFrame: 1 year
measure: all-cause mortality
timeFrame: 1 year
measure: BARC 1-3
timeFrame: 1 year
Locations:
city: Cona
country: Italy
facility: University Hospital of Ferrara
state: Ferrara
Study officials:
References:
citation: Biscaglia S, Tonet E, Pavasini R, Serenelli M, Bugani G, Cimaglia P, Gallo F, Spitaleri G, Del Franco A, Aquila G, Vieceli Dalla Sega F, Tebaldi M, Tumscitz C, Ferrari R, Campo G. A counseling program on nuisance bleeding improves quality of life in patients on dual antiplatelet therapy: A randomized controlled trial. PLoS One. 2017 Aug 23;12(8):e0182124. doi: 10.1371/journal.pone.0182124. eCollection 2017.