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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02554006
Other study ID # 150595
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date March 2017

Study information

Verified date May 2018
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 448
Est. completion date March 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
good clinical practice
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
bundle group
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management

Locations

Country Name City State
Italy University Hospital of Ferrara Cona Ferrara

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 patie — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other ischemic adverse events cumulative incidence of the following ischemic adverse events: cardiac death, myocardial infarction, transient ischemic attack/stroke 1 year
Other all-cause mortality occurrence of all-cause death 1 year
Other BARC 1-3 occurrence of BARC1-3 complications 1 year
Primary quality of life quality of life assessment in each patient by EQ-5D questionnaire 1 month
Secondary emergency room admission number of access to emergency room service for bleeding 1 month
Secondary general practitioner visit number of access to general practitioner for bleeding 1 month
Secondary dyspnea occurrence number of patients suffering dyspnoea stratified according P2Y12 inhibitors 1 month
Secondary bleeding academic research consortium (BARC) 2-3 occurrence of BARC 2-3 complications 1 month
Secondary bleeding academic research consortium (BARC) 1 occurrence of BARC 1 complications 1 month
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