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Trial record 5 of 507 for:    ASPIRIN AND P2

What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2. (WOEST 2)

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ClinicalTrials.gov Identifier: NCT02635230
Recruitment Status : Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
St. Antonius Hospital
Information provided by (Responsible Party):
R&D Cardiologie

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 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.

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 coronory artery bypass grafting (CABG)

Follow-up : 24 months

Visits : 30 days, 12 and 24 months after index PCI or CABG


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]
  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
WOEST2 Registry is designed to recruit an unselected cohort of patients with AF and/or a heart valve prosthesis undergoing coronary revascularisation (PCI/CABG) within at least three European countries (Netherlands, Belgium, United Kingdom). The three international cohorts of patients reflect the spectrum of our study population within the geographic catchment regions. At least 15 hospitals of varying size and characteristics will participate in this study.
Criteria

Inclusion Criteria:

In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria:

  1. Patient is ≥ 18 years of age;
  2. Patients with a diagnosis of atrial fibrillation (prior to hospitalisation ór during hospitalisation within 72h after coronary revascularisation) and/or with a heart valve prosthesis (aortic/mitral);
  3. Chronic treatment with OAC or NOAC therapy at inclusion or the intention to start chronic treatment with OAC or NOAC within 72h after coronary revascularisation AND with intended duration of treatment for at least one year after inclusion in the registry;
  4. Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent);
  5. Prescription of a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel) because of CABG following acute coronary syndrome* and /or because of PCI (with deployment of at least 1 coronary stent).
  6. Patient has provided written informed consent.

Exclusion Criteria:

A potential subject who meets ANY of the following criteria will be excluded from participation in this study:

  1. Patients unable to sign informed consent (including mental disabled patients);
  2. Patients with life expectancy < 1 year;
  3. Allergy or intolerance to P2Y12 inhibitors.

Information from the National Library of Medicine

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


Locations
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Netherlands
Amphia Hospital
Breda, Noord-Brabant, Netherlands, 4818 CK
Sponsors and Collaborators
R&D Cardiologie
St. Antonius Hospital
Investigators
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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

Additional Information:
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Responsible Party: R&D Cardiologie
ClinicalTrials.gov Identifier: NCT02635230     History of Changes
Other Study ID Numbers: R&D/Z14.016/WOEST2
WOEST2-004 ( Other Identifier: WOEST 2 Study Team )
V.21483/W14.007 ( Other Identifier: Medical research Ethics Committees United - St. Antonius Hospital, the Netherlands )
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by R&D Cardiologie:
Aspirin
Atrial Fibrillations
Heart Valve Prostheses
Acute Coronary Syndromes
Percutaneous Coronary Revascularization
Coronary Artery Bypass Grafting
Coronary Artery Diseases
Myocardial Infarction
Ischemic stroke
Bleeding
Thrombosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Platelet Aggregation Inhibitors
Clopidogrel
Ticagrelor
Prasugrel
Antithrombotic treatment
Oral anticoagulation
Warfarin
Dabigatran etexilate mesylate
Apixaban
Rivaroxaban
Direct Factor Xa Inhibitors
Direct Thrombin Inhibitors
Additional relevant MeSH terms:
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Aspirin
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Infarction
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Ischemia
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action