MedTrace Logo

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 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-04

No results posted yet for this study

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)

Interventions

DRUG

Prasugrel

Prasugrel 5 mg od for 30 ± 5 days

DRUG

Clopidogrel

Clopidogrel 75 mg od for 30 ± 5 days

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Dominick J Angiolillo, MD, PhD · University of Florida College of Medicine - Jacksonville

  • Luis Ortega-Paz, MD, PhD · University of Florida College of Medicine - Jacksonville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-08-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025148 on ClinicalTrials.gov