NCT07025148 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)
| NCT ID | NCT07025148 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-10-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with high bleeding risk (defined according to the ARC-HBR criteria) who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin (81mg qd) with clopidogrel (75 mg qd) as part of standard of care for at least 30 days. * Age ≥18 years. * Provide written informed consent. Exclusion Criteria: * Prior cerebrovascular event. * PCI within 30 days. * Hemodynamic instability. * On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis). * Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel. * Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL). * Known hemoglobinopathies or anemia (hemoglobin \<9 g/dL) * Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].
Contact & Investigator
Dominick J Angiolillo, MD, PhD
STUDY CHAIR
University of Florida College of Medicine - Jacksonville
Frequently Asked Questions
Who can join the NCT07025148 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07025148 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07025148 currently recruiting?
Yes, NCT07025148 is actively recruiting participants. Contact the research team at Luis.Ortega@jax.ufl.edu for enrollment information.
Where is the NCT07025148 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07025148 clinical trial?
NCT07025148 is sponsored by University of Florida. The principal investigator is Dominick J Angiolillo, MD, PhD at University of Florida College of Medicine - Jacksonville. The trial plans to enroll 40 participants.