Clinical trial

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism: The Pilot Study

Name

COBRRA Pilot

Description

This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood thinners for the treatment of blood clots. Half of the patients will receive apixaban and half will receive rivaroxaban. The main objective is to determine the feasibility of patient recruitment and resources required to follow enrolled patients and inform for a larger, multi-centered trial and to assess which one is safer.

Trial arms

Trial start

2016-05-01

Estimated PCD

2017-11-01

Trial end

2018-02-01

Status

Completed

Phase

Early phase I

Treatment

Apixaban

Arms:

Apixaban

Other names:

Eliquis

Rivaroxaban

Arms:

Rivaroxaban

Other names:

Xarelto

Size

Primary endpoint

Proportion of patients screened who are eligible to participate in the trial

For the duration of the study 3-6 months

Proportion of eligible patients who consent to participate in the trial

For the duration of the study 3-6 months

Proportion of patients who attend each follow-up visit

For the duration of the study 3-6 months

Proportion of patients completing all required study procedures, per follow-up visit

For the duration of the study 3-6 months

Eligibility criteria

Inclusion Criteria: * Confirmed newly diagnosed acute VTE (proximal lower extremity deep vein thrombosis and segmental or greater pulmonary embolism) * Age ≥ 18 years old * Written informed consent Exclusion Criteria: * Any contraindication for anticoagulation such as active bleeding * Clinically significant liver disease or alanine aminotransferase (ALT) levels ≥ 3 times the upper limit of normal range * Creatinine clearance \< 30 ml/min calculated with the Cockcroft-Gault formula (29) * Known allergies to either apixaban or rivaroxaban * Pregnancy * Use of contraindicated medications with apixaban or rivaroxaban * Active malignancy in the last 6 months (excluding localized skin malignancy) * No private insurance coverage for the study drug or not willing to pay for study drug

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

Updated at

2024-03-18

1 organization

1 drug

1 indication

Organization

Ottawa Hospital Research Institute

Drug

Rivaroxaban

Indication

Venous Thromboembolism