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)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prasugrel

    Drug

    Prasugrel 5 mg od for 30 ± 5 days

  • Clopidogrel

    Drug

    Clopidogrel 75 mg od for 30 ± 5 days

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Dual risk - Clopidogrel-based DAPTExperimental treatment 1 intervention
Group B: Dual risk - Low-dose prasugrel-based DAPTExperimental treatment 1 intervention
Group C: ControlActive comparator 1 intervention

Trial outcomes

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)

Time frame
30 Day

Secondary outcomes

Other outcomes

Sponsors and contacts

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