Tailoring blood thinners after percutaneous coronary interventio

Phase 1

• Conditions: Efficacy of antiplatelet therapy after percutaneous coronary intervention in patients using oral anticoagulants; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-001418-12-NL
• Lead Sponsor: niversity of Florida

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-24
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

•Age = 18 years
•Willing and able to provide written informed consent
•Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care
•On treatment with a novel oral anticoagulant (apixaban, dabigatran, edoxaban, or rivaroxaban) for any indication (dosing regimen will be according to standard of care and at the discretion of the treating physician)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

•Any active bleeding or history of major bleeding
•Ischemic Stroke within 1 month
•Any history of hemorrhagic or lacunar stroke, or intracranial hemorrhage
•Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic
cancer) or that increases the risk of an adverse reaction to study interventions.
•End-stage renal disease on hemodialysis
•Known severe liver dysfunction or any known hepatic disease associated with coagulopathy
•History of hypersensitivity or known contraindication to clopidogrel or ticagrelor.
•Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (e.g.,
systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus
[HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e.
rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
•Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually
active and not practicing an effective method of birth control (e.g. surgically sterile,
prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization)
•Concomitant participation in another study with investigational drug
•Hemoglobin =9 mg/dL
•Platelet count <80x106/mL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified