The Greek AntiPlatElet Atrial Fibrillation Registry.

NCT03362788 | Completed

• 1 other identifier: AttikonHGR
• Study Type: observational
• Target: 654
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atrial Fibrillation; Coronary Artery Disease

Keywords

Antithrombotics Antiplatelets Stents Angioplasty

Outcome Measures

Primary Outcomes (1)

• Clinically significant bleeding

  Clinically significant bleeding defined as Bleeding Academic Research Consortium (BARC) ≥2 between the 2 groups (VKA vs NOACs).

  12 months

Secondary Outcomes (2)

• MACEs

  12 months

• Net clinical endpoint

  12 months

Other Outcomes (5)

• HAS-BLED score

  12 months

• CHA2DS2-VASc Score

  12 months

• Charlson Comorbidity Index (CCI)

  12 months

Study Arms (2)

VKA

Patients receiving VKA as anticoagulant treatment plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily. Treatment will be at operator's discretion or, post discharge, at prescribing physician's discretion.

Drug: VKA

NOAC

Patients receiving a NOAC as anticoagulant treatment plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily. Treatment will be at operator's discretion or, post discharge, at prescribing physician's discretion.

Drug: NOAC

Interventions

VKA DRUG

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

Also known as: Vitamin K antagonist

VKA

NOAC DRUG

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

Also known as: Non-vitamin K oral anticoagulant

NOAC

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients undergoing percutaneous coronary intervention over 1 year period will be screened for atrial fibrillation and need for anticoagulation plus P2Y12 receptor antagonist.

You may qualify if:

• Percutaneous coronary intervention with stent implantation Non-valvular atrial fibrillation (paroxysmal, persistent or permanent) with indication for anticoagulation Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead
• Hellenic Cardiology Society: collaborator

Study Sites (1)

Attikon University Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (2)

• Alexopoulos D, Dragona VM, Varlamos C, Ktenas D, Lianos I, Patsilinakos S, Sionis D, Zarifis I, Bampali T, Poulimenos L, Skalidis E, Pissimisis E, Trikas A, Tsiafoutis I, Kafkas N, Olympios C, Tziakas D, Ziakas A, Voudris V, Kanakakis I, Tsioufis C, Davlouros P, Benetou DR. One-Year Outcomes in Anticoagulated Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the Greek Antiplatelet Atrial Fibrillation Registry. J Cardiovasc Pharmacol. 2023 Feb 1;81(2):141-149. doi: 10.1097/FJC.0000000000001389.

  PMID: 36410034 DERIVED

• Benetou DR, Varlamos C, Ktenas D, Tsiafoutis I, Koutouzis M, Bampali T, Mantis C, Zarifis J, Skalidis E, Aravantinos D, Varvarousis D, Lianos I, Kanakakis J, Pisimisis E, Ziakas A, Davlouros P, Alexopoulos D; GRAPE-AF investigators. Trends of Antithrombotic Treatment in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights from the GReek-AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry. Cardiovasc Drugs Ther. 2021 Feb;35(1):11-20. doi: 10.1007/s10557-020-07090-x. Epub 2020 Oct 9.

  PMID: 33034806 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Interventions

acarboxyprothrombin; N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dimitrios Alexopoulos, MD

  Attikon Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 5, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

GR (1)