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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03362788
Other study ID # AttikonHGR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 31, 2020

Study information

Verified date July 2021
Source Attikon Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 654
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 20 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Greece Attikon University Hospital Athens Attika

Sponsors (2)

Lead Sponsor Collaborator
Attikon Hospital Hellenic Cardiology Society

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Other HAS-BLED score 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. 12 months
Other CHA2DS2-VASc Score 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. 12 months
Other Charlson Comorbidity Index (CCI) Validation of Charlson Comorbidity Index (CCI) in predicting bleeding events and ischemic stroke and evaluation of its impact on antithrombotic medication at discharge. 12 months
Other Anticoagulation and Risk Factors In Atrial Fibrillation (ATRIA) score 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. 12 months
Other Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT) score 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. 12 months
Primary Clinically significant bleeding Clinically significant bleeding defined as Bleeding Academic Research Consortium (BARC) =2 between the 2 groups (VKA vs NOACs). 12 months
Secondary MACEs MACEs (cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism and unplanned coronary revascularization) between the 2 groups (VKA vs NOACs) 12 months
Secondary Net clinical endpoint 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) 12 months
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