Switching from clopidogrel to low-dose prasugrel after PCI in people at high bleeding and ischemic risk

Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)

We will test whether switching adults who had PCI and are at both high bleeding and ischemic risk from standard-dose clopidogrel to low-dose prasugrel lowers platelet reactivity compared with staying on clopidogrel.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT07025148 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized pharmacodynamic Phase 4 study comparing continuation of standard-dose clopidogrel versus switching to low-dose prasugrel in patients judged to be at both high bleeding risk (ARC-HBR) and high ischemic risk (ABCD-GENE score ≥10) after PCI. All participants are on maintenance dual antiplatelet therapy with aspirin 81 mg plus clopidogrel 75 mg daily for at least 30 days before randomization. The primary outcome is platelet reactivity measurements to determine whether switching improves platelet inhibition. The study is conducted at University of Florida Health in Jacksonville and enrolls adults who can give informed consent.

Who should consider this trial

Good fit: Adults (≥18 years) who underwent PCI, have been on aspirin 81 mg plus clopidogrel 75 mg daily for at least 30 days, and meet ARC-HBR criteria plus an ABCD-GENE score ≥10 are the intended participants.

Not a fit: Patients with prior stroke, recent PCI (<30 days), hemodynamic instability, current oral anticoagulant use, hypersensitivity to study drugs, significant thrombocytopenia or anemia, pregnancy, or breastfeeding are excluded and would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, switching to low-dose prasugrel could lower platelet reactivity and potentially reduce ischemic risk in this high-risk group without adding unacceptable bleeding.

How similar studies have performed: Related pharmacodynamic and genotype-guided antiplatelet switching strategies have been tested with mixed results, and low-dose prasugrel in dual-risk populations remains relatively understudied.

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 \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Where this trial is running

Jacksonville, Florida

• University of Florida Health — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Luis Ortega-Paz, MD, PhD — University of Florida College of Medicine - Jacksonville
• Study coordinator: Luis Ortega-Paz, MD, PhD

Conditions Coronary Arterial Disease; Percutaneous Coronary Intervention; Coronary artery disease; Dual antiplatelet therapy; High bleeding risk