WOEST-3

Overview

Sponsor-declared trial summary

Key facts

Sponsor

St Antonius Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

11 Jan 2023 → ongoing

Decision date (initial)

2023-07-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2022-502140-13-00

EudraCT number

2022-001298-30

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

1. To assess bleeding risk (i.e. safety) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.
2. To assess ischemic risk (i.e. efficacy) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.

Secondary objectives 2

1. To assess bleeding risk (i.e. safety) and ischemic risk (i.e. efficacy) with 30-day DAPT compared to standard therapy at 6 months after successful PCI in patients with AF.
2. To perform an exploratory analysis of the individual components of the main secondary endpoint and quality of life.

Conditions and MedDRA coding

Atrial fibrillation Acute coronary syndrome Chronic coronary syndrome

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. ≥18 years of age
2. Undergoing successful 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 18

1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors (e.g. kidney failure (eGFR <15) or allergy)
2. BMI >40 or bariatric surgery
3. Poor LV function (LVEF <30%) with proven slow-flow
4. <12 months after any stroke
5. CHA2DS2VASc score ≥7
6. Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism, mechanical heart valve prosthesis, intracardiac thrombus or apical aneurysm requiring OAC)
7. History of intracranial haemorrhage
8. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
9. Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
10. Life expectancy <1 year
11. Other oral anticoagulation than NOAC or acenocoumarol at randomization (e.g. fenprocoumon)
12. Active malignancy with metastases or non-curative treatment (e.g. palliative chemotherapy)
13. Known coagulopathy
14. Active bleeding on randomization
15. History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved
16. Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.
17. Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 10^9/L
18. Pregnancy or breast-feeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI.
2. The co-primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.

Secondary endpoints 4

1. Key secondary endpoints include the primary safety and efficacy outcomes at 6 months after successful PCI.
2. Exploratory analysis of the individual components of the main secondary endpoint
3. Net clinical benefit comprising of major bleeding, myocardial infarction, stroke, systemic embolism, all cause death, and stent thrombosis
4. Quality of life

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

St Antonius Hospital

Sponsor organisation

St Antonius Hospital

Address

Koekoekslaan 1

City

Nieuwegein

Postcode

3435 CM

Country

Netherlands

Scientific contact point

Organisation

St Antonius Hospital

Contact name

A. Verburg

Public contact point

Organisation

St Antonius Hospital

Contact name

A. Verburg

Locations

4 EU/EEA countries · 45 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

22 submissions — initial application plus substantial / non-substantial modifications