DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid

NCT07391358 | Not Yet Recruiting DMC

• 1 other identifier: 2026-3682
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

High bleeding risk; Complex percutaneous coronary intervention; Double antiplatelet therapy; Patient decision aid

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).

• Preparation for Decision-Making (PrepDM) Score After PDA Use

  Immediately post-PDA completion (Day 0, index hospitalization).

• Patient Acceptability Score of the PDA in Routine Clinical Use

  Immediately post-PDA completion (Day 0, index hospitalization).

• Patient Refusal Rate to Use the PDA and Reasons for Refusal

  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

  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).

Other Outcomes (1)

• Exploratory Subgroup Effects on Decisional Conflict Scores Low Litteracy (DCS-LL) Questionnaire

  Baseline (pre-PDA, Day 0) and immediately post-PDA completion (Day 0, index hospitalization).

Study Arms (1)

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.

Other: Patient decision aid to support shared decision-making between patients and clinicians

Interventions

Patient decision aid to support shared decision-making between patients and clinicians OTHER

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.

High bleeding risk patients treated with complex PCI in the context of ACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Julien Quang Le Van, BPharm, MSc, BCCP

CONTACT

514-376-3330; julienquang.levan@icm-mhi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)