What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2. (WOEST 2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02635230|
Recruitment Status : Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillations Heart Valve Prostheses Acute Coronary Syndromes Coronary Artery Diseases Stroke Bleeding Myocardial Infarction||Drug: Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.|
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.
Name : WOEST 2 REGISTRY
Target for enrollment : 2200 patients
Time frame for inclusion : within 72 hours after index PCI or coronory artery bypass grafting (CABG)
Follow-up : 24 months
Visits : 30 days, 12 and 24 months after index PCI or CABG
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2200 participants|
|Target Follow-Up Duration:||24 Months|
|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.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Patients with chronic oral anticoagulation and P2Y12 inhibitor
Patients with chronic indication for chronic oral anticoagulation (OAC) because of a heart valve prosthesis and/or atrial fibrillation undergoing coronary revascularisation (by PCI or CABG) and requiring concomitant treatment with P2Y12 inhibitors.
Drug: Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
- Composite of the rate of non-fatal myocardial infarction, non-fatal ischemic stroke (including transient ischemic attack), non-central nervous system systemic embolization and cardiovascular death [the primary efficacy outcome]. [ Time Frame: 1 year ]
- The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome]. [ Time Frame: 1 year ]Bleeding will be classified by the Bleeding Academic Research Consortium (BARC) 2, 3, 4 and 5 bleeding criteria and by the Thrombolysis in Myocardial Infarction (TIMI) minor and major bleeding criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635230
|Breda, Noord-Brabant, Netherlands, 4818 CK|
|Principal Investigator:||Jurriën M ten Berg, MD, PhD||St. Antonius Hospital Nieuwegein, the Netherlands|
|Principal Investigator:||Willem JM Dewilde, MD, PhD||Amphia Hospital Breda, the Netherlands|