NCT03362788

The Greek AntiPlatElet Atrial Fibrillation Registry.

Contemporary Antithrombotic Treatment in Patients With Non-valvular AF Undergoing PCI: The Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 654 (actual)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: —

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 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.

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 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.

Conditions

• Atrial Fibrillation
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	VKA	VKA plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
DRUG	NOAC	NOAC plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-12-05
• Last updated: 2021-07-26

Locations

1 site across 1 country: Greece