Atrial FibrillationsWOEST 2NCT02635230
What is the Optimal antiplatElet and Anticoagulant Therapy in Patients With Oral Anticoagulation Undergoing revasculariSaTion 2.
An observational study of Atrial Fibrillations and Heart Valve Prostheses, run by R&D Cardiologie at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillations, Heart Valve Prostheses, Acute Coronary Syndromes
- What is being tested?
- Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
- Type of treatment
- Pill or oral medicine
- How many people
- 2,200 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jun 2014to Jan 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria:
- Patient is ≥ 18 years of age;
- 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);
- 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;
- Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent);
- 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).
- Patient has provided written informed consent.
Who cannot join
- A potential subject who meets ANY of the following criteria will be excluded from participation in this study:
- Patients unable to sign informed consent (including mental disabled patients);
- Patients with life expectancy < 1 year;
- Allergy or intolerance to P2Y12 inhibitors.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Belgium5 sites, 2 recruiting
- Active, not recruiting
Onze Lieve Vrouw Ziekenhuis
Aalst
- Active, not recruiting
Universitair Ziekenhuis Antwerpen
Antwerp
- Recruiting
Imelda Ziekenhuis
Bonheiden
- Recruiting
Ziekenhuis Oost-Limburg
Genk
- Active, not recruiting
Universitair Ziekenhuis Leuven
Leuven
Netherlands4 sites, 1 recruiting
- Active, not recruiting
Onze Lieve Vrouwe Gasthuis
Amsterdam
- Active, not recruiting
Amphia Ziekenhuis
Breda
- Recruiting
St. Antonius Hospital
Nieuwegein
Wilbert Bor, MD, +31640907188, w.bor@antoniusziekenhuis.nl
- Active, not recruiting
Elizabeth-TweeSteden Ziekenhuis
Tilburg
About this study
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.
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.
Read the 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
- Being tested
- Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.
- Keywords
- 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, Aspirin, Clopidogrel, Ticagrelor, Prasugrel, Antithrombotic treatment
- Medical subject headings
- Atrial Fibrillation, Acute Coronary Syndrome, Coronary Artery Disease, Stroke, Hemorrhage, Myocardial Infarction, Ischemic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 1 year
The occurrence of any bleeding episode requiring in-hospital medical attention and/or a switch of antithrombotic medication [the primary safety outcome].
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital
- Responsible party
- Sponsor
- Investigators
- Jurriën M ten Berg, MD, PhD, Principal investigator, St. Antonius Hospital Nieuwegein, the NetherlandsWillem JM Dewilde, MD, PhD, Principal investigator, Imelda Hospital Bonheiden, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635230
- Sponsor's protocol ID
- R&D/Z14.016/WOEST2
- Other IDs
- WOEST2-004, V.21483/W14.007
- Acronym
- WOEST 2
- Status last verified
- Sep 2019
- First submitted
- 10 Dec 2015
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02635230
- Acronym / sponsor ID
- WOEST 2 / R&D/Z14.016/WOEST2
- Conditions
- Atrial Fibrillations, Heart Valve Prostheses, Acute Coronary Syndromes, Coronary Artery Diseases, Stroke, Bleeding
- Keywords
- Atrial Fibrillations, Heart Valve Prostheses, Acute Coronary Syndromes, Percutaneous Coronary Revascularization, Coronary Artery Bypass Grafting, Coronary Artery Diseases, Myocardial Infarction, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Collaborators
- St. Antonius Hospital
- Study start
- Jun 2014
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic oral anticoagulation and P2Y12 inhibitor | – | Drug: Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- In order to be eligible to be included in this registry, a subject must meet ALL of the following criteria:
- Patient is ≥ 18 years of age;
- 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);
- 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;
- Indication for coronary revascularisation by CABG or PCI (with deployment of at least 1 coronary stent);
Key exclusion criteria (4 listed)
- A potential subject who meets ANY of the following criteria will be excluded from participation in this study:
- Patients unable to sign informed consent (including mental disabled patients);
- Patients with life expectancy < 1 year;
- Allergy or intolerance to P2Y12 inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin. | Drug | Patients with chronic oral anticoagulation and P2Y12 inhibitor |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurriën M ten Berg, MD, PhD principal investigator
St. Antonius Hospital Nieuwegein, the Netherlands
Willem JM Dewilde, MD, PhD principal investigator
Imelda Hospital Bonheiden, Belgium
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillations and Heart Valve Prostheses, run by R&D Cardiologie at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilbert Bor, MD (+31640907188, w.bor@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.