Using an algorithm to tailor antiplatelet therapy after heart procedures
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
This study is testing whether using a special scoring system to decide how long heart patients should take their blood-thinning medication after getting a stent can lead to better health outcomes compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2788 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 3 sites (Banja Luka and 2 other locations) |
| Trial ID | NCT05732701 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of a score-based algorithm to determine the duration of dual antiplatelet therapy (DAPT) for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. It compares outcomes between patients receiving algorithm-guided DAPT and those on standard DAPT without risk scores. The study aims to provide direct evidence on the benefits of using risk scores in clinical practice. A total of 2788 patients aged 18 and older will be randomized into two groups to assess the efficacy and safety of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing PCI with drug-eluting stent implantation.
Not a fit: Patients with planned staged PCI, indications for oral anticoagulation, or significant peri-procedural complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective antiplatelet therapy, potentially improving patient outcomes after heart procedures.
How similar studies have performed: Previous studies have suggested the potential benefits of algorithm-guided therapy, but this specific approach is novel and aims to provide direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. PCI with drug eluting stent (DES) implantation 2. Age ≥18 years 3. Ability to sign informed consent before any study-specific procedure Exclusion Criteria: 1. Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization) 2. Indication for oral anticoagulation 3. Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion/no-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding) 4. Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI 5. Active bleeding requiring medical attention at qualifying PCI 6. The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices) 7. Life expectancy less than 1 year 8. Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) 9. Planned surgery within the next 3 months 10. Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel) 11. Participation in a drug trial
Where this trial is running
Banja Luka and 2 other locations
- University Clinical Center of the Republic of Srpska — Banja Luka, Bosnia and Herzegovina (Recruiting)
- UOC Cardiologia San Giovanni Addolorata Hospital — Roma, Italy (Recruiting)
- Department of Cardiology, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Miklos Rohla, MD, PhD — Department of Cardiology, Bern University Hospital, Bern, Switzerland
- Study coordinator: Lorenz Räber, MD, PhD
- Email: Lorenz.raeber@insel.ch
- Phone: +41 31 632 09 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.