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Clinical Trials in Italy / NCT05732701
Recruiting Not applicable

Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions

NCT05732701 · tracked via the Priya Life Science Italy tracker
Sponsor
Insel Gruppe AG, University Hospital Bern
Phase
Not applicable
Started
2023-06-27
Last updated
2025-09-16

Condition(s) studied

Percutaneous Coronary InterventionPlatelet Aggregation InhibitorsCoronary Artery Disease

Investigational drug(s) / intervention(s)

Algorithm-guided DAPT durationStandard-of-care DAPT duration

Algorithm-guided DAPT duration: PRECISE-DAPT score ≥25 * Chronic Coronary Syndromes (CCS): Aspirin + clopidogrel for 1 month, followed by clopidogrel monotherapy * Acute Coronary Syndromes (ACS): Aspirin + ticagrelor for 1 month, followed by ticagrelor monotherapy PRECISE-DAPT score \<25: * Non-complex CCS: Aspirin + clopidogrel for 6 months, followed by clopidogrel monotherapy * Non-complex ACS: Aspirin + potent P2Y12 inhibitor for 6 months, followed by potent P2Y12 inhibitor monotherapy * Complex CCS or ACS: Aspirin + P2Y12 inhibitor for 12 months, followed by P2Y12 inhibitor monotherapy (potent P2Y12 inhibitor mandatory for ACS)

Standard-of-care DAPT duration: DAPT strategy at the operators´ discretion in accordance with applicable guidelines

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Net adverse clinical events (NACE) — 1 year
    All-cause death, spontaneous myocardial infarction, definite stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding

Trial sites (3)

FacilityCityRegionStatus
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

More Insel Gruppe AG, University Hospital Bern trials in Italy

Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants Recruiting
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation Recruiting
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention Recruiting

Other trials for the same condition

Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque Starting soon
Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS Recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease Recruiting
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System Recruiting
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05732701 on ClinicalTrials.gov ↗ ← All trials in Italy