NCT05732701

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,788 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: 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. European guidelines recommend to implement risk scores to guide the duration of DAPT after stent implantation (class IIb, level of evidence A). However, its adoption rate remains exceedingly low in daily clinical practice in part due to the lack of direct evidence obtained from a randomized controlled trial supporting this strategy. Aim: Using a pragmatic study-design, the investigators aim to determine the efficacy and safety of an algorithm-guided strategy for DAPT duration compared to a standard-of-care DAPT without the use of risk scores in patients undergoing PCI with stent implantation. Methodology: This investigator-initiated, single-blind, randomized trial will include a total of 2788 patients aged ≥18 years undergoing PCI with stent implantation. Main exclusion criteria are peri-procedural complications potentially affecting DAPT duration. The study will be nested into a well-running registry to minimize study-related costs (pragmatic trial approach). Patients will be randomized to an algorithm-guided DAPT group or a standard-of-care DAPT group in a 1:1 fashion. In the algorithm-guided group, DAPT duration will be determined according to the PRECISE-DAPT score (≥25 or \<25), PCI complexity, and clinical presentation (acute or chronic coronary syndromes). In the standard-of-care DAPT group, treatment duration is at the operator's discretion. The primary endpoint is a composite of net adverse clinical events (NACE) defined as all-cause death, spontaneous myocardial infarction, stroke, definite stent thrombosis or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding at 1 year. Potential significance: This will be the first study evaluating the impact of a score-based decision-making algorithm integrating bleeding and ischemic risks for DAPT duration among patients undergoing PCI. The hypothesis is that the proposed simple decision-making algorithm minimizes bleeding risk and maximizes ischemic benefit compared to a standard-of-care DAPT regimen. Prospective data obtained from a pragmatic randomized controlled trial embedded into an on-going, well-managed PCI registry database may further enhance the adoption rate of such a strategy in clinical practice.

Conditions

• Percutaneous Coronary Intervention
• Platelet Aggregation Inhibitors
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	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)
OTHER	Standard-of-care DAPT duration	DAPT strategy at the operators´ discretion in accordance with applicable guidelines

Timeline

• Start date: 2023-06-27
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2023-02-17
• Last updated: 2025-09-16

Locations

3 sites across 3 countries: Bosnia and Herzegovina, Italy, Switzerland