Clinical Trials Logo
NCT number NCT03362788
Study type Observational [Patient Registry]
Source Attikon Hospital
Contact Dimitrios Alexopoulos, MD
Phone 302105831213
Status Recruiting
Phase N/A
Start date December 1, 2017
Completion date June 2020

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Recruiting NCT03226262 - FFRangio Accuracy vs. Standard FFR N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Completed NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03284229 - Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD N/A
Not yet recruiting NCT03252990 - 18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability N/A
Not yet recruiting NCT03231527 - Outcomes of Total Arterial Coronary Artery Bypass Grafting N/A
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography) N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Active, not recruiting NCT02693158 - The Direct III Post Market Study N/A
Enrolling by invitation NCT02894255 - Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents Phase 4
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A
Not yet recruiting NCT02863952 - Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI N/A
Completed NCT03025685 - "TransRadial Ultra Support Technique" (TRUST) N/A