Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Greek AntiPlatElet Atrial Fibrillation Registry. (GRAPE-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362788
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Hellenic Cardiological Society
Information provided by (Responsible Party):
Dimitrios Alexopoulos, Attikon Hospital

Tracking Information
First Submitted Date November 24, 2017
First Posted Date December 5, 2017
Last Update Posted Date July 14, 2020
Actual Study Start Date December 1, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2017)
Clinically significant bleeding [ Time Frame: 12 months ]
Clinically significant bleeding defined as Bleeding Academic Research Consortium (BARC) ≥2 between the 2 groups (VKA vs NOACs).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2017)
  • MACEs [ Time Frame: 12 months ]
    MACEs (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism and unplanned coronary revascularization) between the 2 groups (VKA vs NOACs)
  • Net clinical endpoint [ 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2017)
  • HAS-BLED score [ 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.
  • CHA2DS2-VASc Score [ 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.
  • Charlson Comorbidity Index (CCI) [ 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.
  • Anticoagulation and Risk Factors In Atrial Fibrillation (ATRIA) score [ 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.
  • Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT) score [ 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Greek AntiPlatElet Atrial Fibrillation Registry.
Official Title Contemporary Antithrombotic Treatment in Patients With Non-valvular AF Undergoing PCI: The Greek AntiPlatElet Atrial Fibrillation (GRAPE-AF) Registry.
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition
  • Atrial Fibrillation
  • Coronary Artery Disease
Intervention
  • Drug: VKA
    VKA plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
    Other Name: Vitamin K antagonist
  • Drug: NOAC
    NOAC plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
    Other Name: Non-vitamin K oral anticoagulant
Study Groups/Cohorts
  • 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.

    Intervention: 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.

    Intervention: Drug: NOAC
Publications * 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. 2020 Oct 9. doi: 10.1007/s10557-020-07090-x. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2020)
654
Original Estimated Enrollment
 (submitted: December 4, 2017)
550
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  1. Any clinically significant bleeding (BARC ≥2) at the time of screening or within the previous month
  2. Prior intracranial bleeding
  3. Dialysis or calculated creatinine clearance <30 mL/min at screening
  4. 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
  5. 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.
  6. Life expectancy of less than 12 months
  7. 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)
  8. Planned coronary artery bypass grafting
  9. 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).
  10. Estimated high risk of non-availability for follow-up visits
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Dimitrios Alexopoulos, MD 302105831213 dalex@med.uoa.gr
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT03362788
Other Study ID Numbers AttikonHGR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dimitrios Alexopoulos, Attikon Hospital
Study Sponsor Attikon Hospital
Collaborators Hellenic Cardiological Society
Investigators
Principal Investigator: Dimitrios Alexopoulos, MD ATTIKON University Hospital
PRS Account Attikon Hospital
Verification Date July 2020