Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03012906
Status:
UNKNOWN
Last Update Posted:
2017-01-06
First Post:
2017-01-05
Brief Title:
Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score 1 Undergoing Percutaneous Coronary Interventions
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score 1 Undergoing Percutaneous Coronary Interventions
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients undergoing percutaneous coronary intervention PCI with stent implantation and requiring chronic anticoagulation for atrial fibrillation AF with a CHA2DS2-VASc 1 are required to receive triple antithrombotic therapy This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist VKA or an oral anticoagulant NOAC
Recently NOAC inhibiting the IIa dabigatran or Xa rivaroxaban and apixaban in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc 1 Interestingly NOAC are associated with a reduced fatal bleeding rate compared to VKA Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents
Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated However they are based on an expert consensus because of the scarce data available
These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 25 The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study In the recently published ESC guidelines on the management of atrial fibrillation despite the lack of new data the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months
The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy
Recently NOAC inhibiting the IIa dabigatran or Xa rivaroxaban and apixaban in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc 1 Interestingly NOAC are associated with a reduced fatal bleeding rate compared to VKA Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents
Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated However they are based on an expert consensus because of the scarce data available
These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 25 The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study In the recently published ESC guidelines on the management of atrial fibrillation despite the lack of new data the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months
The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None