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)

NCT07025148 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB202401774
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Coronary artery disease; Dual antiplatelet therapy; High bleeding risk

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity measured as PRU

  The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system in patients at dual-risk (both HBR and HIR \[ABCD-GENE score ≥10 points\]) between low-dose prasugrel (5 mg qd) vs. standard-dose clopidogrel (75 mg qd)

  30 Day

Study Arms (3)

Dual risk - Clopidogrel-based DAPT

EXPERIMENTAL

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.

Drug: Clopidogrel

Dual risk - Low-dose prasugrel-based DAPT

EXPERIMENTAL

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.

Drug: Prasugrel

Control

ACTIVE COMPARATOR

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.

Drug: Clopidogrel

Interventions

Prasugrel DRUG

Prasugrel 5 mg od for 30 ± 5 days

Dual risk - Low-dose prasugrel-based DAPT

Clopidogrel DRUG

Clopidogrel 75 mg od for 30 ± 5 days

Control; Dual risk - Clopidogrel-based DAPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Health

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dominick J Angiolillo, MD, PhD

  University of Florida College of Medicine - Jacksonville

  STUDY CHAIR

• Luis Ortega-Paz, MD, PhD

  University of Florida College of Medicine - Jacksonville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Ortega-Paz, MD, PhD

CONTACT

904-244 2060; Luis.Ortega@jax.ufl.edu

Andrea Burton, MPH, CCRP

CONTACT

904-244-5617; Andrea.Burton@jax.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual patient data will be shared upon reasonable request to the primary investigator after publication of the primary results.
• Access Criteria: Individual patient data will be shared upon reasonable request to the primary investigator.

Locations

US (1)