Attikon University Hospital
Athens, Attica, 12462, Greece
NCT Number: NCT03362788
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 receptor antagonist, mainly due to non-valvular atrial fibrillation. Advent of non-vitamin K antagonist oral anticoagulants (NOAC) increased treatment options, while there is cumulative evidence that dual combination of NOAC and P2Y12 receptor antagonist attenuates bleeding without compromising efficacy. Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) is an observational study of non-valvular atrial fibrillation patients undergoing percutaneous coronary intervention, planning to enroll >500 participants during 1 year period in Greece. Patients will be followed-up at 1, 6 and 12 months post hospital discharge. Key data to be collected pre-discharge include demographics, detailed past medical history, antithrombotic and concomitant treatment. Study's primary endpoint is clinically significant bleeding defined as Bleeding Academic Research Consortium (BARC) ≥2) at 12 months, between vitamin K antagonists (VKAs) and NOACs-treated patients. All clinical events will be adjudicated by an independent endpoint committee.This study would provide "real world" information on current antithrombotic treatment patterns and clinical outcome of patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention.
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Notify Me20 year–100 year
All sexes
Observational
Athens, Attica, 12462, Greece
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 treating physician.
Follow-up visits will be performed at 1, 6 and 12 months post-percutaneous coronary intervention by telephone contact or personal interview. All outcome and adverse events will be adjudicated by an independent endpoint committee. All data will be recorded in electronic forms and multiple quality controls will be performed both electronically and on-site to ensure data integrity.
Platelet reactivity substudy:Patients receiving either clopidogrel or ticagrelor as part of their (dual or triple) combination therapy, will be eligible for sub-study of platelet function assessment with the VerifyNow assay at 1 month post-percutaneous coronary intervention in centers with test availability.
Sub-study's endpoints will be platelet reactivity between groups and high platelet reactivity rate between groups.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Percutaneous coronary intervention with stent implantation Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) with indication for anticoagulation Written informed consent
Exclusion criteria
VKA plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
Other names: Vitamin K antagonist
NOAC plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
Other names: Non-vitamin K oral anticoagulant
Time frame: 12 months
Clinically significant bleeding defined as Bleeding Academic Research Consortium (BARC) ≥2 between the 2 groups (VKA vs NOACs).
Time frame: 12 months
MACEs (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism and unplanned coronary revascularization) between the 2 groups (VKA vs NOACs)
Time frame: 12 months
Net clinical endpoint includes cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, unplanned coronary revascularization and BARC ≥2 bleedings between the 2 groups (VKA vs NOACs)
Time frame: 12 months
Validation of baseline HAS-BLED score (between 0 and 9) in predicting bleeding events and evaluation of their impact on antithrombotic medication at discharge. Higher values represent a worse outcome.
Time frame: 12 months
Validation of CHA2DS2-VASc Score (between 0 and 9) in predicting ischemic stroke and evaluation of its impact on antithrombotic medication at discharge.Higher values represent a worse outcome.
Time frame: 12 months
Validation of Charlson Comorbidity Index (CCI) in predicting bleeding events and ischemic stroke and evaluation of its impact on antithrombotic medication at discharge.
Time frame: 12 months
Validation of ATRIA score (0 to 15) in predicting bleeding events and evaluation of their impact on antithrombotic medication at discharge. Higher values represent a worse outcome.
Time frame: 12 months
Validation of ORBIT score (0 to 7) in predicting bleeding events and evaluation of their impact on antithrombotic medication at discharge.Higher values represent a worse outcome.
Attikon Hospital
Other
Contemporary Antithrombotic Treatment in Patients With Non-valvular AF Undergoing PCI: The Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry.
Acronym: GRAPE-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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