Ignite Creation Date:
2024-05-06 @ 7:56 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02635230
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2015-12-10
Brief Title:
What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2
Sponsor:
RD Cardiologie
Organization:
RD Cardiologie
Study Overview
Official Title:
An International Prospective Registry on Concomitant Use of Oral Anticoagulants and P2Y12 Inhibitors in Patients With Atrial Fibrillation or Heart Valve Prosthesis Undergoing Coronary Revascularisation
Status:
UNKNOWN
Status Verified Date:
2019-09
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:
WOEST 2
Brief Summary:
The optimal antithrombotic therapy for patients with atrial fibrillation AF with a CHA2DS2-VASc score 1 with concomitant acute coronary syndrome ACS or revascularisation by percutaneous coronary intervention PCI with stenting is still unknown For these patients current North American and European guidelines recommend a triple therapy strategy including vitamin K antagonists VKA aspirin and clopidogrel A major drawback of this triple therapy strategy is a significant increase in the risk of major bleeding Furthermore the ommitance of aspirin and the introduction of more potent P2Y12 inhibitors as well as the non-vitamin K oral anticoagulants NOAC created numerous new antithrombotic treatment strategies for these patients with overlapping conditions To date evidence on the risks and benefits of these new antithrombotic treatment strategies is lacking
The WOEST 2 Registry aims to improve medical care for patients with AF andor a heart valve prosthesis ánd undergoing coronary revascularisation through a better understanding of their demographics antithrombotic management and related in-hospital and long-term outcomes The WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment patterns and patient outcomes
Objective To assess the different management patterns and related in-hospital and long-term safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12 inhibitor in patients with atrial fibrillation andor a heart valve prosthesis undergoing coronary revascularisation
The WOEST 2 Registry aims to improve medical care for patients with AF andor a heart valve prosthesis ánd undergoing coronary revascularisation through a better understanding of their demographics antithrombotic management and related in-hospital and long-term outcomes The WOEST 2 Registry will provide data to support benchmarking of antithrombotic treatment patterns and patient outcomes
Objective To assess the different management patterns and related in-hospital and long-term safety and efficacy outcomes of combined use of chronic oral anticoagulation and a P2Y12 inhibitor in patients with atrial fibrillation andor a heart valve prosthesis undergoing coronary revascularisation
Detailed Description:
The WOEST 2 Registry is a prospective international multi-centre non-interventional cohort study designed to recruit an unselected cohort of patients with atrial fibrillation andor a heart valve prosthesis undergoing coronary revascularisation
Trial overview
Name WOEST 2 REGISTRY
Target for enrollment 2200 patients
Time frame for inclusion within 72 hours after index PCI or coronary artery bypass grafting CABG
Follow-up 24 months
Visits 30 days 12 and 24 months after index PCI or CABG
Trial overview
Name WOEST 2 REGISTRY
Target for enrollment 2200 patients
Time frame for inclusion within 72 hours after index PCI or coronary artery bypass grafting CABG
Follow-up 24 months
Visits 30 days 12 and 24 months after index PCI or CABG
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WOEST2-004 | OTHER | None | None |
| V21483W14007 | OTHER | Medical research Ethics Committees United - St Antonius Hospital the Netherlands | None |