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Switching from Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention: TAILOR-BLEED-2 study

  • Status
    Accepting Candidates
  • Age
    18 Years - 99 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

Studies have shown that the blood-thinning effects of clopidogrel can be influenced by your genetics and clinical characteristics. A scoring system called the ABCD-GENE score is used to assess whether clopidogrel will likely achieve effective blood-thinning effects. This score considers genetic factors along with clinical factors such as age, weight, kidney function, and diabetes status. If your score is low (ABCDGENE score < 10), clopidogrel is more likely to provide effective blood-thinning effects. However, if your score is high (ABCD-GENE score ≥ 10), clopidogrel may be less effective, increasing the risk of stent clotting and heart attacks. In these latter cases, alternative medications like prasugrel (Effient) may be considered. While prasugrel is highly effective at preventing stent clotting, it also carries a higher risk of

bleeding, especially when used at the standard 10 mg dose. To address this, a lower 5 mg dose of prasugrel has shown to reduce bleeding risk while still providing adequate protection against heart attacks.

Many patients are at both high risk of bleeding and high risk of clotting. In these cases, a low dose of prasugrel (5 mg) may be a suitable option for patients with a high clotting risk (ABCD-GENE score ≥ 10) and a high bleeding risk (according to ARC-HBR criteria). However, there is currently limited information on how this low dose of prasugrel affects blood thinning (i.e., how platelets stick together) in patients who meet both of these risk criteria, which is the focus of this study.

Details

Protocol number IRB202401774

Eligibility

Inclusion: 

  1. Patients with HBR (defined according to the HBR-ARC 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.
  2. Age ≥18 years
  3. Provide written informed consent.

 

Exclusion:

  1. Prior cerebrovascular event
  2. PCI within 30 days
  3. Hemodynamic instability
  4. 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)
  5. Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel
  6. Known hematologic malignancies or thrombocytopenia (platelet count <80x106/mL)
  7. Known hemoglobinopathies or anemia (hemoglobin <9 g/dL)
  8. Pregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study].

 

 

Lead researchers

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  2. Step
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