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)

University of Florida

Status and phase: Enrolling; Phase 4

Conditions: Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI)

Treatments: Drug: Clopidogrel; Drug: Prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT07025148

IRB202401774

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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].

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Dual risk - Clopidogrel-based DAPT

Experimental group

Description:

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.

Treatment:

Drug: Clopidogrel

Dual risk - Low-dose prasugrel-based DAPT

Experimental group

Description:

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.

Treatment:

Drug: Prasugrel

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Clopidogrel