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Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
RECRUITINGN/ASponsored by Insel Gruppe AG, University Hospital Bern
Actively Recruiting
PhaseN/A
SponsorInsel Gruppe AG, University Hospital Bern
Started2023-06-27
Est. completion2027-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05732701
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
Coronary Artery DiseaseHeart DiseasePercutaneous Coronary InterventionPlatelet Aggregation Inhibitors
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Actively Recruiting
PhaseN/A
SponsorInsel Gruppe AG, University Hospital Bern
Started2023-06-27
Est. completion2027-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05732701