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

NCT ID: NCT04436978

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Coronary Syndrome Myocardial Infarction Atrial Fibrillation Atrial Flutter STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Bleeding Stroke Stent Thrombosis Embolism Coronary Artery Disease

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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First month DAPT

30-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.

Group Type ACTIVE_COMPARATOR

30-day DAPT

Intervention Type DRUG

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 therapy

Standard 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.

Group Type ACTIVE_COMPARATOR

Guideline-directed therapy

Intervention Type DRUG

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

Interventions

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30-day DAPT

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.

Intervention Type DRUG

Guideline-directed therapy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jurriën M. ten Berg, MD, PhD

Professor dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jurriën M ten Berg, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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ASZ Aalst

Aalst, , Belgium

Site Status RECRUITING

UZ Antwerpen

Antwerp, , Belgium

Site Status RECRUITING

Imelda Ziekenhuis

Bonheiden, , Belgium

Site Status RECRUITING

UZ Brussel

Brussels, , Belgium

Site Status RECRUITING

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status RECRUITING

AZ Maria Middelares Gent

Ghent, , Belgium

Site Status RECRUITING

Jan Yperman

Ieper, , Belgium

Site Status NOT_YET_RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

OLVG

Amsterdam, , Netherlands

Site Status RECRUITING

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status RECRUITING

Treant Zorggroep

Emmen, , Netherlands

Site Status RECRUITING

Zuyderland Ziekenhuis

Heerlen, , Netherlands

Site Status NOT_YET_RECRUITING

Tergooi MC

Hilversum, , Netherlands

Site Status RECRUITING

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

Hagaziekenhuis

The Hague, , Netherlands

Site Status RECRUITING

Elisabeth Tweesteden Ziekenhuis

Tilburg, , Netherlands

Site Status RECRUITING

Countries

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Belgium Netherlands

Central Contacts

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Ashley Verburg, MD

Role: CONTACT

Phone: +31 (0)88 320 0925

Email: [email protected]

Facility Contacts

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Rosseel

Role: primary

Vandendriessche

Role: primary

Dewilde

Role: primary

Vandeloo

Role: primary

Ferdinande

Role: primary

Cornelis

Role: primary

De Keyser

Role: primary

van mieghem, MD PhD

Role: primary

Adriaenssens

Role: primary

Dujardin

Role: primary

Heestermans

Role: primary

Simao Henriques, MD PhD

Role: primary

Vink

Role: primary

Vlaar

Role: primary

Ruifrok

Role: primary

Van 't hof

Role: primary

Plomp

Role: primary

Jurrien ten berg, MD PhD

Role: primary

Schotborgh

Role: primary

Magro

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39007830 (View on PubMed)

Other Identifiers

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2022-001298-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL81102.100.22

Identifier Type: -

Identifier Source: org_study_id