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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Royal College Of Surgeons In Ireland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

19 Jul 2024 → 10 Apr 2025

Decision date (initial)

2023-06-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

INVENT-VTE Network

External identifiers

EU CT number

2023-504179-26-00

ClinicalTrials.gov

NCT03266783

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To compare the safety of apixaban and rivaroxaban for treatment of VTE.

Conditions and MedDRA coding

Acute Venous Thromboembolism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1.  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 6

1. Have received > 72 hours of therapeutic anticoagulation
2. Creatinine clearance < 30 ml/min calculated with the Cockcroft-Gault formula
3. Use of any other investigational medicinal product within previous 12 weeks
4. Co-enrolment in another trial of an investigational medicinal product
5. • Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 of the SmPC for Rivaroxaban or Apixaban
6. • Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to: o active bleeding, o active 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, o weight >120 kg, o hepatic disease associated with coagulopathy and clinically relevant bleeding risk o known liver disease (Child-Pugh B or C), o use of contraindicated medications (see Section 6.4) o another indication for long-term anticoagulation (e.g. atrial fibrillation) o pregnant* 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome is the rate of adjudicated clinically relevant bleeding (CRB) events defined as the composite of major bleeding (MB) events and/or clinically relevant non-major bleeding events (CRNMB).

Secondary endpoints 1

1. a) adjudicated MB events; b) adjudicated CRNMB events; c) adjudicated recurrent VTE events; d) adjudicated VTE-related deaths; e) all-cause mortality; f) medication adherence; g) incremental cost-effectiveness ratios, including cost per one CRB case prevented, cost per one life year saved and cost per one quality-adjusted life year (QALY) gained; h) impact of verbal consent on patient participation in comparison with participants from sites using written informed consent.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Royal College Of Surgeons In Ireland

Sponsor organisation

Royal College Of Surgeons In Ireland

Address

123 Saint Stephen's Green

City

Dublin 2

Postcode

D02 YN77

Country

Ireland

Scientific contact point

Organisation

Royal College Of Surgeons In Ireland

Contact name

Mandy Jackson

Public contact point

Organisation

Royal College Of Surgeons In Ireland

Contact name

Mandy Jackson

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

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

Application history

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