Trials / Unknown
UnknownNCT02635230
What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,200 (estimated)
- Sponsor
- R&D Cardiologie · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 and/or 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 and/or 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 and/or 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
Conditions
- Atrial Fibrillations
- Heart Valve Prostheses
- Acute Coronary Syndromes
- Coronary Artery Diseases
- Stroke
- Bleeding
- Myocardial Infarction
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin. |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2021-01-01
- Completion
- 2022-01-01
- First posted
- 2015-12-18
- Last updated
- 2020-03-11
Locations
9 sites across 2 countries: Belgium, Netherlands
Source: ClinicalTrials.gov record NCT02635230. Inclusion in this directory is not an endorsement.