NCT02554006

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

September 17, 2015

Last Update Submit

May 1, 2018

Conditions

Myocardial IschemiaHemorrhageQuality of LifePlatelet Aggregation Inhibitors

Outcome Measures

Primary Outcomes (1)

  • quality of life

    quality of life assessment in each patient by EQ-5D questionnaire

    1 month

Secondary Outcomes (5)

  • emergency room admission

    1 month

  • general practitioner visit

    1 month

  • dyspnea occurrence

    1 month

  • bleeding academic research consortium (BARC) 2-3

    1 month

  • bleeding academic research consortium (BARC) 1

    1 month

Other Outcomes (3)

  • ischemic adverse events

    1 year

  • all-cause mortality

    1 year

  • BARC 1-3

    1 year

Study Arms (2)

good clinical practice

OTHER

all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process

Behavioral: good clinical practice

bundle group

EXPERIMENTAL

patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling)

Behavioral: bundle group

Interventions

good clinical practiceBEHAVIORAL

education from physician regarding dual antiplatelet therapy as part of the routine discharge process

Also known as: standard of care
good clinical practice
bundle groupBEHAVIORAL

visits and materials describing advantages and side effects of dual antiplatelet therapy and their management

Also known as: counseling regarding dual antiplatelet therapy management
bundle group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • oral anticoagulant therapy
  • bleeding event in the 30 days before the enrolment
  • planned surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Related 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 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.

    PMID: 28832589RESULT

MeSH Terms

Conditions

Myocardial IschemiaHemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
interventional cardiologist and assistant professor

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

IT(1)