Acute Coronary SyndromeBETA-DAPTNCT07391358
DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid
A study testing Patient decision aid to support shared decision-making between patients and clinicians in people with Acute Coronary Syndrome, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at high thrombotic risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Patient decision aid to support shared decision-making between patients and clinicians
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or older
- Hospitalized on the coronary care unit ward at the Montreal Heart Institute (MHI)
- Acute coronary syndrome (ACS) during the current episode of care, treated with PCI and placement of one or more coronary stents
- High bleeding risk based on PRECISE-HBR score and high thrombotic risk, with both risks considered of comparable clinical importance by the treating medical team
- Clinicians working in the MHI coronary care unit (cardiologists, medical residents, nurse practitioners, or pharmacists) who use the patient decision aid with one or more study participants
Who cannot join
- Receiving therapeutic anticoagulation
- Planned cardiac surgery during the same episode of care
- Prior history of coronary stent thrombosis
- Antiphospholipid syndrome or known thrombophilia
- Unable to participate in shared decision-making
- Unable to understand spoken and written French or English
- Concurrent participation in another study (followed within another research protocol)
- Transferred from another center for reasons other than coronary angiography at MHI and expected to return to the referring center for ongoing care (i.e., "fly-in/fly-out" patients)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Julien Quang Le Van, 514-376-3330 ext. 3510, julienquang.levan@icm-mhi.org
About this study
Official title: Dual Antiplatelet Therapy Strategy in High Bleeding Risk Patients Undergoing Complex Percutaneous Coronary Intervention Following Acute Coronary Syndrome: Second-Phase Beta Testing of a Patients Decision Aid
Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at high thrombotic risk. In this population, several dual antiplatelet therapy (DAPT) strategies may be considered: (1) de-escalation of DAPT intensity after 1 to 3 months (switch from ticagrelor/prasugrel to clopidogrel), (2) shortening DAPT duration to 1 to 3 months followed by antiplatelet monotherapy, (3) 12-month clopidogrel-based DAPT, and (4) 12-month ticagrelor/prasugrel-based DAPT. Selecting the most appropriate DAPT strategy in this dual-risk context is complex, and clinical trial evidence is limited for this specific subgroup. In the absence of clear guideline recommendations to support decision-making for patients facing both elevated bleeding and thrombotic risks, structured shared decision-making support is needed.
In this context, within research project 2025-3499 conducted with pharmacy residents, we developed a patient decision aid (PDA) designed to support shared decision-making by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy. The PDA aims to facilitate shared decisions by improving patients' understanding of benefits and harms and aligning choices with patient values. A preliminary version of the tool has already undergone alpha testing with a small group of internal users (physicians, pharmacists, and patient partners). The next step is beta testing, that is, real-world testing with the target population and clinicians to evaluate usability and acceptability in routine practice.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Patient decision aid to support shared decision-making between patients and clinicians
- Keywords
- High bleeding risk, Complex percutaneous coronary intervention, Double antiplatelet therapy, Patient decision aid
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient decision aid to support shared decision-making between patients and cliniciansOther
Patient decision aid to support shared decision-making between patients and clinicians by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| High bleeding risk patients treated with complex PCI in the context of ACS | Other | The intervention is the use of the Patient Decision Aid (PDA) to support shared decision-making between patients and clinicians after PCI, assessed using questionnaires capturing multiple dimensions of decision quality.
No pharmacologic treatment is administered as part of the study; exposure consists solely of complete use of the PDA according to the protocol.
The study includes a single pre-post group, no interim analyses are planned given the limited project duration, and a single beta-testing phase will be conducted. Receives: Other: Patient decision aid to support shared decision-making between patients and clinicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Decisional Conflict (DCS-LL) After Use of the Patient Decision Aid (PDA)
Change in total score on the low-literacy Decisional Conflict Scale (DCS-LL; Ottawa Hospital Research Institute), comparing pre-PDA vs post-PDA completion. Lower scores indicate less decisional conflict.
Measured: Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).
Secondary outcomes (7)
Change in Antiplatelet Strategy Knowledge Score After PDA Use
Change in total score on an adapted OHRI knowledge questionnaire assessing understanding of bleeding and thrombotic risks and DAPT options, comparing pre-PDA vs post-PDA completion.
Measured: Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).
Preparation for Decision-Making (PrepDM) Score After PDA Use
Total score on the Preparation for Decision Making (PrepDM; OHRI) questionnaire completed after PDA use. Higher scores indicate greater perceived preparedness to make a decision with the clinician.
Measured: Immediately post-PDA completion (Day 0, index hospitalization).
Patient Acceptability Score of the PDA in Routine Clinical Use
Total score on an OHRI acceptability questionnaire completed after PDA use, reflecting perceived relevance, clarity, length, and overall acceptability in the clinical setting.
Measured: Immediately post-PDA completion (Day 0, index hospitalization).
Patient Refusal Rate to Use the PDA and Reasons for Refusal
Number and proportion of eligible patients who personally refuse participation/PDA use, and categorization of documented reasons for refusal (e.g., not interested, too tired, overwhelmed, language barriers, time constraints).
Measured: Pre-intervention (at the time of the consent request, prior to PDA delivery, during the index hospitalization).
Agreement Between Patient-Preferred Antiplatelet Strategy and Strategy Prescribed at Hospital Discharge
Proportion of agreement between (a) the antiplatelet strategy preferred by the patient as identified through the PDA and (b) the antiplatelet strategy documented on the discharge prescription/orders.
Measured: At hospital discharge (index hospitalization), comparing the patient preference recorded immediately after PDA completion with the antiplatelet strategy on the discharge prescription/orders (also post-PDA completion).
Clinician Usability of the PDA (French System Usability Scale, F-SUS)
Total score on the French System Usability Scale (F-SUS) completed by clinicians after using the PDA with an included patient in routine clinical care. Higher scores indicate better usability.
Measured: Day 0 (immediately after PDA use with an included patient)
Clinician Refusal Rate to Use the PDA and Reasons for Non-Use
Number and proportion of eligible patient encounters in which the clinician declines to use the PDA when asked, along with categorization of documented reasons (e.g., time constraints, clinical instability, workflow barriers, clinician preference).
Measured: Pre-intervention (at the time the clinician is asked whether it is appropriate to approach the patient and offer the PDA, prior to patient approach and prior to PDA delivery, during the index hospitalization).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Quang Le Van, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391358
- Sponsor's protocol ID
- 2026-3682
- Acronym
- BETA-DAPT
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Antiplatelet Therapy Strategy in High Bleeding Risk Patients Undergoing Complex Percutaneous Coronary Intervention Following Acute Coronary Syndrome: Second-Phase Beta Testing of a Patients Decision Aid
- ClinicalTrials.gov ID
- NCT07391358
- Acronym / sponsor ID
- BETA-DAPT / 2026-3682
- Conditions
- Acute Coronary Syndrome
- Keywords
- High bleeding risk, Complex percutaneous coronary intervention, Double antiplatelet therapy, Patient decision aid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- 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.
Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at high thrombotic risk. In this population, several dual antiplatelet therapy (DAPT) strategies may be considered: (1) de-escalation of DAPT intensity after 1 to 3 months (switch from ticagrelor/prasugrel to clopidogrel), (2) shortening DAPT duration to 1 to 3 months followed by antiplatelet monotherapy, (3) 12-month clopidogrel-based DAPT, and (4) 12-month ticagrelor/prasugrel-based DAPT. Selecting the most appropriate DAPT strategy in this dual-risk context is complex, and clinical trial evidence is limited for this specific subgroup. In the absence of clear guideline recommendations to support decision-making for patients facing both elevated bleeding and thrombotic risks, structured shared decision-making support is needed.
In this context, within research project 2025-3499 conducted with pharmacy residents, we developed a patient decision aid (PDA) designed to support shared decision-making by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy. The PDA aims to facilitate shared decisions by improving patients' understanding of benefits and harms and aligning choices with patient values. A preliminary version of the tool has already undergone alpha testing with a small group of internal users (physicians, pharmacists, and patient partners). The next step is beta testing, that is, real-world testing with the target population and clinicians to evaluate usability and acceptability in routine practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High bleeding risk patients treated with complex PCI in the context of ACS | Other | Other: Patient decision aid to support shared decision-making between patients and cliniciansThe intervention is the use of the Patient Decision Aid (PDA) to support shared decision-making between patients and clinicians after PCI, assessed using questionnaires capturing multiple dimensions of decision quality. No pharmacologic treatment is administered as part of the study; exposure consists solely of complete use of the PDA according to the protocol. The study includes a single pre-post group, no interim analyses are planned given the limited project duration, and a single beta-testing phase will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Hospitalized on the coronary care unit ward at the Montreal Heart Institute (MHI)
- Acute coronary syndrome (ACS) during the current episode of care, treated with PCI and placement of one or more coronary stents
- High bleeding risk based on PRECISE-HBR score and high thrombotic risk, with both risks considered of comparable clinical importance by the treating medical team
- Clinicians working in the MHI coronary care unit (cardiologists, medical residents, nurse practitioners, or pharmacists) who use the patient decision aid with one or more study participants
Key exclusion criteria (8 listed)
- Receiving therapeutic anticoagulation
- Planned cardiac surgery during the same episode of care
- Prior history of coronary stent thrombosis
- Antiphospholipid syndrome or known thrombophilia
- Unable to participate in shared decision-making
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 |
|---|---|---|
| Patient decision aid to support shared decision-making between patients and cliniciansPatient decision aid to support shared decision-making between patients and clinicians by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy. | Other | High bleeding risk patients treated with complex PCI in the context of ACS |
Primary outcome
Change in Decisional Conflict (DCS-LL) After Use of the Patient Decision Aid (PDA)
Time frame: Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).
Change in total score on the low-literacy Decisional Conflict Scale (DCS-LL; Ottawa Hospital Research Institute), comparing pre-PDA vs post-PDA completion. Lower scores indicate less decisional conflict.
7 secondary outcomes
Change in Antiplatelet Strategy Knowledge Score After PDA Use
Time frame: Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).
Preparation for Decision-Making (PrepDM) Score After PDA Use
Time frame: Immediately post-PDA completion (Day 0, index hospitalization).
Patient Acceptability Score of the PDA in Routine Clinical Use
Time frame: Immediately post-PDA completion (Day 0, index hospitalization).
Patient Refusal Rate to Use the PDA and Reasons for Refusal
Time frame: Pre-intervention (at the time of the consent request, prior to PDA delivery, during the index hospitalization).
Agreement Between Patient-Preferred Antiplatelet Strategy and Strategy Prescribed at Hospital Discharge
Time frame: At hospital discharge (index hospitalization), comparing the patient preference recorded immediately after PDA completion with the antiplatelet strategy on the discharge prescription/orders (also post-PDA completion).
Clinician Usability of the PDA (French System Usability Scale, F-SUS)
Time frame: Day 0 (immediately after PDA use with an included patient)
Clinician Refusal Rate to Use the PDA and Reasons for Non-Use
Time frame: Pre-intervention (at the time the clinician is asked whether it is appropriate to approach the patient and offer the PDA, prior to patient approach and prior to PDA delivery, during the index hospitalization).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient decision aid to support shared decision-making between patients and clinicians in people with Acute Coronary Syndrome, run by Montreal Heart Institute at 1 site in Canada.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Quang Le Van, BPharm, MSc, BCCP (514-376-3330 ext. 5076, julienquang.levan@icm-mhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Decisional Conflict (DCS-LL) After Use of the Patient Decision Aid (PDA) (time frame: Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.