COmparison of Bleeding Risk between Rivaroxaban andApixaban for the treatment of acute venous thromboembolism

Phase 1

• Conditions: Acute Venous Thromboembolism; MedDRA version: 21.1Level: LLTClassification code: 10066899Term: Venous thromboembolism Class: 10047065; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-504179-26-00
• Lead Sponsor: Royal College Of Surgeons In Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2760

Inclusion Criteria

? Symptomatic acute VTE (proximal lower extremity DVT or segmental or greater PE) ? Age = 18 years old ? Provide informed consent - Ability to comprehend the Patient Information Leaflet and to provide signed and dated informed consent - Women of childbearing potential must be using effective contraception (see section 5.3 of main protocol) - Negative urine pregnancy test at Visit 1 required for all females including those presenting with oligomenorrhea or amenorrhea who are =55 years (unless permanently sterile)

Exclusion Criteria

Have received > 72 hours of therapeutic anticoagulation, Creatinine clearance < 30 ml/min calculated with the Cockcroft-Gault formula, Use of any other investigational medicinal product within previous 12 weeks, Co-enrolment in another trial of an investigational medicinal product, •Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 of the SmPC for Rivaroxaban or Apixaban, •Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to: oactive bleeding, oactive malignancy, defined as the following: a) diagnosed with cancer within the past 6 months; or b) recurrent, regionally advanced or metastatic disease; or c) currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or d) a hematologic malignancy not in complete remission, oweight >120 kg, ohepatic disease associated with coagulopathy and clinically relevant bleeding risk oknown liver disease (Child-Pugh B or C), ouse of contraindicated medications (see Section 6.4) oanother indication for long-term anticoagulation (e.g. atrial fibrillation) opregnant* or breastfeeding *As reported by the patient or a pregnancy test will be ordered at the discretion of the treating physician for women of childbearing potential as per standard of care.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified