Status:
COMPLETED
The Greek AntiPlatElet Atrial Fibrillation Registry.
Lead Sponsor:
Attikon Hospital
Collaborating Sponsors:
Hellenic Cardiology Society
Conditions:
Atrial Fibrillation
Coronary Artery Disease
Eligibility:
All Genders
20-100 years
Brief Summary
Approximately 5% to 7% of patients undergoing percutaneous coronary intervention for the treatment of coronary artery disease, require chronic oral anticoagulation on top of aspirin and a P2Y12 recept...
Detailed Description
All consecutive patients undergoing percutaneous coronary intervention over 1 year period will be screened for participation. Discharge antithrombotic medication will be at the discretion of the treat...
Eligibility Criteria
Inclusion
- Percutaneous coronary intervention with stent implantation Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) with indication for anticoagulation Written informed consent
Exclusion
- Any clinically significant bleeding (BARC ≥2) at the time of screening or within the previous month
- Prior intracranial bleeding
- Dialysis or calculated creatinine clearance \<30 mL/min at screening
- Known significant liver disease (eg, acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test abnormalities at screening (confirmed with repeat testing): alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal
- A PT or INR test result that is higher than the upper limit of normal at the time of screening that suggests an underlying coagulation disorder (except for subjects taking VKA), or an INR that does not drop to 2.5 or below by 72 h after sheath removal following the index procedure.
- Life expectancy of less than 12 months
- Incomplete staged percutaneous coronary intervention procedure (once the completion of the staged procedure has occurred, the final percutaneous coronary intervention PCI may become the index event and is allowed)
- Planned coronary artery bypass grafting
- Contraindications to the use of clopidogrel or ticagrelor or NOAC, per prescribing information (e.gHypersensitivity to the active substance or to any of the excipients or co-administration with strong CYP3A4 inhibitors e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir).
- Estimated high risk of non-availability for follow-up visits
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT03362788
Start Date
December 1 2017
End Date
December 31 2020
Last Update
July 26 2021
Active Locations (1)
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1
Attikon University Hospital
Athens, Attica, Greece, 12462