Actively Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-09-16
2788
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of aspirin combined with a P2Y12 inhibitor, known as dual antiplatelet therapy (DAPT), which is the standard treatment for patients undergoing percutaneous coronary intervention (PCI) with stent placement. The trial aims to compare a score-based decision-making method for determining DAPT duration against the usual care approach that does not use such risk scores. This study is a randomized, single-blind trial designed to provide direct evidence on whether using risk scores improves patient outcomes. The study will include 2788 patients aged 18 years and older who have undergone PCI with stent implantation. Participants will be randomly assigned to one of two groups: an algorithm-guided DAPT duration group where therapy length is decided based on the PRECISE-DAPT score, PCI complexity, and clinical condition, or a standard-of-care group where treatment duration is left to the operator's discretion. The algorithm group uses specific treatment plans based on risk scores and clinical presentation, with therapy lasting from 1 month up to 12 months followed by monotherapy. Participants will be monitored over one year to assess various outcomes including death, myocardial infarction, stroke, stent thrombosis, and bleeding events. The main measure is a composite of net adverse clinical events (NACE) occurring within one year. The study will also track adherence to therapy and other cardiovascular events. Safety and effectiveness will be evaluated to understand if the algorithm-guided approach better balances bleeding and ischemic risks compared to standard care.
CONDITIONS
Brief Title
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Undergoing percutaneous coronary intervention (PCI) with drug-eluting stent implantation
- Ability to provide informed consent before any study-specific procedure
You will not qualify if you...
- Planned staged PCI with remaining lesions intended for treatment
- Need for oral anticoagulation therapy
- Peri-procedural complications affecting DAPT regimen, such as untreated flow-limiting complications or stent thrombosis
- Treatment for stent thrombosis at qualifying PCI or within 1 year prior
- Active bleeding requiring medical attention at qualifying PCI
- Hemodynamic instability (low blood pressure, need for catecholamines, signs of hypoperfusion, or use of ventricular assist devices)
- Life expectancy less than 1 year
- Women of childbearing potential who are fertile and not permanently sterile or post-menopausal
- Planned surgery within the next 3 months
- Allergy or contraindication to aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel)
- Participation in another drug trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on assigned treatment group and clinical factors
Participants receive dual antiplatelet therapy (DAPT) tailored by an algorithm or standard care after percutaneous coronary intervention (PCI) with stent implantation. The duration of therapy varies based on clinical presentation, risk scores, and procedural complexity.
Visits as scheduled according to treatment and clinical follow-up
Duration - 1 year
Participants are monitored for safety and outcomes including adverse clinical events, bleeding, and cardiovascular events for 1 year after PCI.
Periodic visits during the year following treatment
Trial Site Locations
Total: 3 locations
1
University Clinical Center of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
Actively Recruiting
2
UOC Cardiologia San Giovanni Addolorata Hospital
Roma, Italy, 00184
Actively Recruiting
3
Department of Cardiology, Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
L
Lorenz Räber, MD, PhD
M
Miklos Rohla, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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