NCT05732701 Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
| NCT ID | NCT05732701 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Percutaneous Coronary Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,788 participants |
| Start Date | 2023-06-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,788 participants in total. It began in 2023-06-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.
Eligibility 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
Contact & Investigator
Lorenz Räber, MD, PhD
STUDY CHAIR
Department of Cardiology, Bern University Hospital, Bern, Switzerland
Frequently Asked Questions
Who can join the NCT05732701 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Percutaneous Coronary Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05732701 currently recruiting?
Yes, NCT05732701 is actively recruiting participants. Contact the research team at Lorenz.raeber@insel.ch for enrollment information.
Where is the NCT05732701 trial being conducted?
This trial is being conducted at Banja Luka, Bosnia and Herzegovina, Roma, Italy, Bern, Switzerland.
Who is sponsoring the NCT05732701 clinical trial?
NCT05732701 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Lorenz Räber, MD, PhD at Department of Cardiology, Bern University Hospital, Bern, Switzerland. The trial plans to enroll 2,788 participants.