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Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)

StatusRecruiting
PhasePhase 4
Started2025-10-01
View on ClinicalTrials.gov ↗

Amendment history

2025-10-31
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-15→confirmed 2025-10-01
Study sitesdetails revised at 1 of 1 site
2025-08-21
minor
Study Status v1
Start date2025-08-01→2025-09-15
2025-06-09
minor
Original filing
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.
Trial Details
NCT Number NCT07025148
Lead Sponsor University of Florida
Conditions Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Enrollment 40 participants
Start Date 2025-10-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-04