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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dual risk - Clopidogrel-based DAPT

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.

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Clopidogrel 75 mg od for 30 ± 5 days

Dual risk - Low-dose prasugrel-based DAPT

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.

Group Type EXPERIMENTAL

Prasugrel

Intervention Type DRUG

Prasugrel 5 mg od for 30 ± 5 days

Control

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.

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Clopidogrel 75 mg od for 30 ± 5 days

Interventions

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Prasugrel

Prasugrel 5 mg od for 30 ± 5 days

Intervention Type DRUG

Clopidogrel

Clopidogrel 75 mg od for 30 ± 5 days

Intervention Type DRUG

Eligibility Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No