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)

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT07025148
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Arterial Disease (CAD)
  • Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prasugrel — DRUG
    Prasugrel 5 mg od for 30 ± 5 days
  • Clopidogrel — DRUG
    Clopidogrel 75 mg od for 30 ± 5 days

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dual risk - Clopidogrel-based DAPT
    Patients deemed at high risk for both bleeding and ischemic risk randomized to continue clopdiogrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.
  • Experimental: Dual risk - Low-dose prasugrel-based DAPT
    Patients deemed at high risk for both bleeding and ischemic risk randomized to receive low-dose prasugrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.
  • Active Comparator: Control
    Patients deemed at high risk for both bleeding but not at high risk for ischemic events being actively treated with clopidogrel-based DAPT as per standard of care. High bleeding riks will be defined according to the Academic Research Consortium definition.

Primary Outcome Measure

Platelet reactivity measured as PRU [ Time Frame: 30 Day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida HealthJacksonvilleFlorida32209
Luis Ortega-Paz, MD, PhD
[email protected]
904-244-2060

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By research site
University of Florida Health· Jacksonville, FL

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