Weight-loss Effects aNd absorption of Direct oral anticoagulants in roux-en-Y gastric bypass patients: a prospective study (WENDY)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC Stichting

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2025-05-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacodynamic, Pharmacokinetic

To assess the difference in the pharmacokinetics of apixaban before and after RYGB

Secondary objectives 2

1. Influence of weight reduction on absorption of apixaban
2. Occurrence of clinical outcomes, such as incidence of bleeding events or thrombotic events, during follow-up

Conditions and MedDRA coding

Roux-en-Y gastric bypass

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Patients who are screened and approved to undergo laparoscopic ggastric bypass
2. Age 18 years or older

Exclusion criteria 12

1. Symptomatic thrombos at inclusion
2. Inability to adhere to treatment or to the follow-up visits
3. Current use of anticoagulant medication, such as apixaban, rivaroxaban, edoxaban, dabigatran, acenocoumarol, fenprocoumon, low molecular weighted heparin or heparin
4. Major bleeding defined according to the International Society on Thrombosis and Haemostasis in the 6 months prior to start participation
5. Liver cirrhosis
6. Severe renal insufficiency (eGFR <30 ml/min/1.73 m2)
7. Concurrent use of strong inhibitors or inducers of cytochrome P450 or P-glycoprotein
8. Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than six months, or unwillingness to sign informed consent
9. Known bleeding diathesis or bleeding disorder
10. Use of antiplatelet agent or chronic use of NSAID
11. Known allergy to apixaban
12. Inadequate or lack of contraceptive methods by the patient when relevant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Area under the curve (AUC) of anti-Xa levels comparing at multiple timepoints: baseline (prior to surgery), +/-17 days untill 60days after surgery, +/-3 months after surgery

Secondary endpoints 2

1. Measured weight and BMI at follow-up visit +3 months in relation to AUC anti-Xa difference
2. Frequence of major bleeding events as defined per ISTH criteria, and incidence of VTE, including pulmonary embolism and deep vein thrombosis

Investigational products

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

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

Sponsor organisation

Amsterdam UMC Stichting

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. M. Coppens

Public contact point

Organisation

Amsterdam UMC Stichting

Contact name

Dr. M. Coppens

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 5 files

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

Application history

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