Myocardial IschemiaBATMANNCT02554006
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
A study testing good clinical practice and bundle group in people with Myocardial Ischemia and Hemorrhage, run by University Hospital of Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Hemorrhage, Quality of Life
- What is being tested?
- good clinical practice and bundle group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- oral anticoagulant therapy
- bleeding event in the 30 days before the enrolment
- planned surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- 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.
- Being tested
- good clinical practice, bundle group
- Medical subject headings
- Myocardial Ischemia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
good clinical practiceBehavioural
Also called standard of care
education from physician regarding dual antiplatelet therapy as part of the routine discharge process
bundle groupBehavioural
Also called counseling regarding dual antiplatelet therapy management
visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
| Study group | Role | What they receive |
|---|---|---|
| good clinical practice | Other | all patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process Receives: Behavioral: good clinical practice |
| bundle group | Experimental | patients assigned to the bundle group will receive visits and materials as described by the protocol (counseling) Receives: Behavioral: bundle group |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
quality of life assessment in each patient by EQ-5D questionnaire
Measured: 1 month
Secondary outcomes (5)
emergency room admission
number of access to emergency room service for bleeding
Measured: 1 month
general practitioner visit
number of access to general practitioner for bleeding
Measured: 1 month
dyspnea occurrence
number of patients suffering dyspnoea stratified according P2Y12 inhibitors
Measured: 1 month
bleeding academic research consortium (BARC) 2-3
occurrence of BARC 2-3 complications
Measured: 1 month
bleeding academic research consortium (BARC) 1
occurrence of BARC 1 complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554006
- Sponsor's protocol ID
- 150595
- Acronym
- BATMAN
- Status last verified
- May 2018
- First submitted
- 17 Sep 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28832589
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02554006
- Acronym / sponsor ID
- BATMAN / 150595
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good clinical practice | Other | Behavioral: good clinical practiceall patients will receive education from physician regarding management of dual antiplatelet therapy as part of the routine discharge process |
| bundle group | Experimental | Behavioral: bundle grouppatients assigned to the bundle group will receive visits and materials as described by the protocol (counseling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- oral anticoagulant therapy
- bleeding event in the 30 days before the enrolment
- planned surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| good clinical practiceAlso: standard of careeducation from physician regarding dual antiplatelet therapy as part of the routine discharge process | Behavioural | good clinical practice |
| bundle groupAlso: counseling regarding dual antiplatelet therapy managementvisits and materials describing advantages and side effects of dual antiplatelet therapy and their management | Behavioural | bundle group |
Primary outcome
quality of life
Time frame: 1 month
quality of life assessment in each patient by EQ-5D questionnaire
5 secondary outcomes
emergency room admission
Time frame: 1 month
general practitioner visit
Time frame: 1 month
dyspnea occurrence
Time frame: 1 month
bleeding academic research consortium (BARC) 2-3
Time frame: 1 month
bleeding academic research consortium (BARC) 1
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Results publication: PubMed 28832589Biscaglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing good clinical practice and bundle group in people with Myocardial Ischemia and Hemorrhage, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02554006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.