AzTrials
AzTrials

Acute Coronary SyndromePhase 4WOEST-3NCT04436978

What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?

A Phase 4 study testing 30-day DAPT and Guideline-directed therapy in people with Acute Coronary Syndrome and Myocardial Infarction, run by St. Antonius Hospital at 20 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
30-day DAPT and Guideline-directed therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
20 sitesin 2 countries
Study dates
11 Jan 2023to 1 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Patients ≥ 18 years
  • Undergoing successful PCI (either ACS or elective PCI)
  • History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC

Who cannot join

  • Contra indication to edoxaban, aspirin or all P2Y12 inhibitors
  • Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
  • <12 months after any stroke
  • CHADSVASc score ≥7
  • Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
  • Mechanical heart valve prosthesis
Show all 20Show fewer
  • Intracardiac thrombus or apical aneurysm requiring OAC
  • Poor LV function (LVEF <30%) with proven slow-flow
  • History of intracranial haemorrhage
  • Active bleeding on randomization
  • History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved
  • Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.
  • Known coagulopathy
  • Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 109/L
  • BMI >40 or bariatric surgery
  • Kidney failure (eGFR <15)
  • Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
  • Active malignancy excluding non-melanoma skin cancer
  • Life expectancy <1 year
  • Pregnancy or breast-feeding women

Trial locations and contacts

20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Ashley Verburg, MD contact

+31 (0)88 320 0925

as.verburg@antoniusziekenhuis.nl

20 sites in 2 countries

Belgium10 sites, 10 recruiting

  • ASZ Aalst

    Aalst

    Rosseel

    Recruiting

  • UZ Antwerpen

    Antwerp

    Vandendriessche

    Recruiting

  • Imelda Ziekenhuis

    Bonheiden

    Dewilde

    Recruiting

  • UZ Brussel

    Brussels

    Vandeloo

    Recruiting

  • Ziekenhuis Oost-Limburg

    Genk

    Ferdinande

    Recruiting

  • AZ Maria Middelares Gent

    Ghent

    Cornelis

    Recruiting

  • Jan Yperman

    Ieper

    De Keyser

    Not yet recruiting

  • AZ Groeninge

    Kortrijk

    van mieghem, MD PhD

    Recruiting

  • UZ Leuven

    Leuven

    Adriaenssens

    Recruiting

  • AZ Delta

    Roeselare

    Dujardin

    Recruiting

Other trials in Belgium

Netherlands10 sites, 10 recruiting

  • Noordwest Ziekenhuisgroep

    Alkmaar

    Heestermans

    Recruiting

  • Amsterdam UMC

    Amsterdam

    Simao Henriques, MD PhD

    Recruiting

  • OLVG

    Amsterdam

    Vink

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Vlaar

    Recruiting

  • Treant Zorggroep

    Emmen

    Ruifrok

    Recruiting

  • Zuyderland Ziekenhuis

    Heerlen

    Van 't hof

    Not yet recruiting

  • Tergooi MC

    Hilversum

    Plomp

    Recruiting

  • St. Antonius Hospital

    Nieuwegein

    Jurrien ten berg, MD PhD

    Recruiting

  • Hagaziekenhuis

    The Hague

    Schotborgh

    Recruiting

  • Elisabeth Tweesteden Ziekenhuis

    Tilburg

    Magro

    Recruiting

Other trials in Netherlands

About this study

Official title: What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?

The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy.

However, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest.

The WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.

Being tested
30-day DAPT, Guideline-directed therapy
Keywords
Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation, Atrial Flutter, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Oral Anticoagulant, NOAC - Novel Oral Anticoagulant, DOAC - Direct Oral Anticoagulant, DAPT - Dual Antiplatelet Therapy, Antithrombotic Therapy, Dual Therapy, Triple Therapy, Bleeding, Thrombosis, Stroke, Stent Thrombosis, Systemic Embolism, Percutaneous coronary intervention, Coronary artery disease
Medical subject headings
Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation, Atrial Flutter, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Hemorrhage, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30-day DAPTDrug

    DAPT (aspirin + P2Y12 inhibitor) during the first 30 days following PCI. After 30 days, all patients will be treated with edoxaban and a P2Y12 inhibitor.

  • Guideline-directed therapyDrug

    Guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)

Study groups in NCT04436978
Study groupRoleWhat they receive
First month DAPTActive comparator30-day DAPT (aspirin + P2Y12 inhibitor). After 30 days all patients will be treated with edoxaban and P2Y12 inhibitor. Selection of P2Y12 inhibitor is at the discretion of the treating physician, depending on both bleeding and ischemic risk. Dosage of aspirin and P2Y12 inhibitor is according to local guidelines. NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.
Receives: Drug: 30-day DAPT
Guideline-directed therapyActive comparatorStandard guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients). After 30 days all patients will be treated with edoxaban and P2Y12 inhibitor. Selection of P2Y12 inhibitor is at the discretion of the treating physician, depending on both bleeding and ischemic risk. Dosage of aspirin and P2Y12 inhibitor is according to local guidelines. NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.
Receives: Drug: Guideline-directed therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary safety endpoint

    Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis

    Measured: 6 weeks

  2. Primary efficacy endpoint

    Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis

    Measured: 6 weeks

Secondary outcomes (11)

  1. Bleeding complications

    Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis

    Measured: 6 months

  2. Thrombotic complications

    Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis

    Measured: 6 months

  3. Net clinical benefit

    Composite of major bleeding, myocardial infarction, stroke, systemic embolism all-cause death and stent thrombosis

    Measured: 6 weeks, 3 months, 6 months

  4. Clinical symptom severity

    CCS grade

    Measured: 6 weeks, 3 months, 6 months

  5. All-cause death

    All-cause death as defined by ARC-2 and SCTI

    Measured: 6 weeks, 3 months, 6 months

  6. Myocardial infarction

    Myocardial infarction as defined by the 4th Universal Definition of Myocardial Infarction

    Measured: 6 weeks, 3 months, 6 months

  7. Stroke

    Stroke as defined by VARC-2 definitions

    Measured: 6 weeks, 3 months, 6 months

  8. Systemic embolism

    Systemic embolism according to ENTRUST-AF PCI definition

    Measured: 6 weeks, 3 months, 6 months

  9. Stent thrombosis

    Stent thrombosis as defined by ARC-2

    Measured: 6 weeks, 3 months, 6 months

  10. Major bleeding

    Major bleeding as defined by BARC 3 or 5

    Measured: 6 weeks, 3 months, 6 months

  11. Clinically relevant non-major bleeding

    CRNM as defined by BARC 2

    Measured: 6 weeks, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2020
  2. Study start11 Jan 2023
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is designed as a multicentre open label randomized controlled superiority trial with regards to safety and non-inferiority trial with regards to efficacy. Participating study centres will enrol patients undergoing PCI who have previously or newly diagnosed AF and indication for NOAC. As soon as possible, but within 72 hours after PCI, patients will be randomized 1:1 to either * 30 days DAPT (asprin + P2Y12 inhibitor), followed by guideline-directed therapy (edoxaban + P2Y12 inhibitor) * Standard guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04436978
Sponsor's protocol ID
NL81102.100.22
Other IDs
2022-001298-30
Acronym
WOEST-3
Status last verified
Dec 2023
First submitted
16 Jun 2020
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will individual participant data be available? Yes What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). What other documents will be available? Study Protocol, informed consent form, clinical study report When will data be available (start and end dates)? Within 1 year following article publication. End date to be determined. With whom? Researchers who provide a methodologically sound proposal. For what types of analyses? To achieve aims in the approved proposal. By what mechanism will data be made available? Proposals should be directed to as.verburg@antoniusziekenhuis.nl. To gain access, data requestors will need to sign a data access agreement.

Publications

  • Verburg A, Bor WL, Kucuk IT, Henriques JPS, Vink MA, Ruifrok WT, Plomp J, Heestermans TACM, Schotborgh CE, Vlaar PJ, Magro M, Rikken SAOF, van den Broek WWA, van Mieghem CAG, Cornelis K, Rosseel L, Dujardin KS, Vandeloo B, Vandendriessche T, Ferdinande B, van 't Hof AWJ, Tijssen JGP, Limbruno U, De Caterina R, Rubboli A, Angiolillo DJ, Adriaenssens T, Dewilde W, Ten Berg JM. Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial. EuroIntervention. 2024 Jul 15;20(14):e898-e904. doi: 10.4244/EIJ-D-24-00100.

    PubMed 39007830

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 30-day DAPT and Guideline-directed therapy in people with Acute Coronary Syndrome and Myocardial Infarction, run by St. Antonius Hospital at 20 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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ashley Verburg, MD (+31 (0)88 320 0925, as.verburg@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary safety endpoint (time frame: 6 weeks). 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?

On the ClinicalTrials.gov record for NCT04436978, which also lists 1 linked publication.

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 15 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in