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Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Study acronym: TAILOR BLEED
StatusRecruiting
PhasePhase 4
Started2023-02-15
View on ClinicalTrials.gov ↗

Amendment history

2026-03-06
Study Status v7
Primary completion date2026-01-31→2026-12-31
Completion date2026-03-31→2027-03-31
2026-02-10
Study Status v6
Re-verified, no change to tracked fields
2025-11-04
Study Status v5
Primary completion date2025-07-31→2026-01-31
Completion date2025-12-15→2026-03-31
2025-01-30
Study Status v4
Primary completion date2024-12-31→2025-07-31
Completion date2025-04-15→2025-12-15
2024-08-06
Study Status v3
Primary completion date2024-10-15→2024-12-31
Completion date2024-12-15→2025-04-15
Show 2 earlier versions
2023-07-24
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2023-02-16
Study Status, Arms and Interventions, Eligibility v1
Eligibility criteria+295 characters
Inclusion Criteria: Patients who presented with chronic coronary syndrome, underwent PCI and have been on maintenance treatment with D [...] el (10 mg od) or ticagrelor (90 mg bid) for at least 30 days. Or patients that presented with an Acute coronary syndrome (ACS) event and underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10mg od) or ticagrelor (90mg bid) for 3 months or greater. Age ≥18 years old Provide written informed consent Exclusion [...]
2023-01-04
Original filing
Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.
Trial Details
NCT Number NCT05681702
Lead Sponsor University of Florida
Conditions Coronary Artery Disease
Enrollment 90 participants
Start Date 2023-02-15
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-09