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TAILOR-BLEED-2: Prasugrel vs. Clopidogrel After PCI

This study is looking at how different antiplatelet medicines work in people who have had a procedure called PCI (Percutaneous Coronary Intervention) for coronary artery disease (blocked heart arteries). You might be able to join if you are already taking aspirin and clopidogrel (a blood thinner) and have a high risk of both bleeding and blood clots. The study will compare taking a lower dose of prasugrel (another blood thinner) to continuing with your usual clopidogrel. Researchers want to see if prasugrel is better at preventing blood clots by measuring how well your platelets (tiny blood cells that help form clots) respond. The study is currently recruiting about 40 participants, but its exact status is unclear.

Study design
This is a randomized study, meaning participants will be assigned by chance to one of two treatment groups. It involves about 40 participants.
What's involved
Participants will take either prasugrel 5 mg daily or clopidogrel 75 mg daily for 30 days. Platelet reactivity will be measured at 30 days.
Compensation
Not stated in the trial record.
Follow-up
Platelet reactivity will be measured at 30 days after starting the study medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07025148

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)

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Florida
~40 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:PrasugrelClopidogrel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Platelet reactivity measured as PRU
Measured over 30 Day

Conditions

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

Explore related trials

Coronary Artery Disease

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Dominick J Angiolillo, MD, PhD · STUDY_CHAIR · University of Florida College of Medicine - Jacksonville
  • Luis Ortega-Paz, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Florida College of Medicine - Jacksonville

Who to contact

Luis Ortega-Paz, MD, PhD
[email protected]
904-244 2060
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Platelet reactivity measured as PRU30 Day

    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)