Status:
COMPLETED
Switching From Ticagrelor to Clopidogrel in Patients With Coronary Artery Disease
Lead Sponsor:
University of Florida
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The recommended antiplatelet treatment regimen for patients affected by acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the combination of aspi...
Detailed Description
The recommended antiplatelet treatment regimen for patients affected by acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI) consists in the combination of aspi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients with angiographically documented CAD
- On therapy with aspirin(\<100mg/day) and clopidogrel (75mg/day) for at least 30 days per standard of care
- Age between 18 and 80 years old
- Exclusion Criteria
- History of intracranial bleeding
- Severe hepatic impairment (ALT \>2.5 times the upper limit of normal)
- Active bleeding or propensity to bleed or blood dycrasia
- Platelet count \<80x106/mL
- Hemoglobin \<10g/dL
- Hemodynamic instability
- Estimated glomerular filtration rate (eGFR) \<30 mL/min
- On treatment with oral anticoagulants
- Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker protection
- Drugs interfering CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
- Pregnant females \[women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study\].
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT02287909
Start Date
December 1 2014
End Date
March 1 2018
Last Update
September 16 2020
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209