Tailoring P2Y12 Inhibiting Therapy in Patients requiring Oral Anticoagulation after undergoing Percutaneous Coronary Intervention: The Switching Anti-Platelet and Anti-Coagulant Therapy - 2 Study
- Conditions
- coronary artery diseasepercutaneous coronary intervention1001108210003216
- Registration Number
- NL-OMON52027
- Lead Sponsor
- niversity of Florida College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
• 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)
• 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Level of platelet reactivity measured by VerifyNow (PRU units)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional exploratory end points will include the comparisons between<br /><br>clopidogrel-treated patients with ABCD-Gene score<10 and the other 2 arms, as<br /><br>well as comparisons between groups of rates of HPR. </p><br>