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Anticoagulant

Rivaroxaban vs Apixaban for Blood Clots (COBRRA Trial)

Q: Has the Apixaban group received governmental authorization for use?

<p><a href="https://www.withpower.com/clinical-trials/apixaban">Apixaban</a>'s efficacy has been established through Phase 4 trials, so it receives a rating of 3 for safety.</p>

Phase 4

Recruiting

Led By Lana Castellucci, MD, FRCPC

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Confirmed newly diagnosed symptomatic acute venous thromboembolism (VTE) [proximal lower extremity deep vein thrombosis (DVT) or segmental or greater pulmonary embolism (PE)]

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of the study: 3 months

Awards & highlights

COBRRA Trial Summary

This trial will compare the safety of apixaban and rivaroxaban, two drugs used to treat venous thromboembolism (VTE).

Who is the study for?

Adults over 18 with a new diagnosis of acute venous thromboembolism (VTE), including deep vein thrombosis or pulmonary embolism, can join this trial. They must not have had more than 72 hours of anticoagulation treatment and should have adequate kidney function. People with active bleeding, certain liver diseases, heavy body weight, or those on conflicting medications cannot participate.Check my eligibility

What is being tested?

This study compares the safety of two blood thinners—Rivaroxaban and Apixaban—in treating VTE. It's a head-to-head test to see which causes fewer bleeding problems in patients. The trial is multi-center and designed so that neither the participants nor the outcome assessors know who receives which drug.See study design

What are the potential side effects?

Both Rivaroxaban and Apixaban may increase the risk of bleeding events such as nosebleeds, heavier menstrual flow, bruising easily, prolonged bleeding from cuts, increased risk of internal bleeds like stomach or brain hemorrhages.

COBRRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have a new diagnosis of a serious blood clot in my leg or lungs.

COBRRA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of the study: 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of the study: 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study: 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemorrhage

Secondary outcome measures

Adjudicated Clinically Relevant Non-Major Bleeding events

Adjudicated Major Bleeding events

Adjudicated VTE-related deaths

+6 more

COBRRA Trial Design

2Treatment groups

Active Control

Group I: Apixaban groupActive Control1 Intervention

10 mg orally (PO), twice a day (BID) for 1 week, then 5 mg PO BID for 3 months of treatment

Group II: Rivaroxaban groupActive Control1 Intervention

15 mg orally (PO), twice a day (BID) for 3 weeks, then 20 mg PO once a day (OD) for 3 months of treatment

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,450,807 Total Patients Enrolled

11 Trials studying Deep Vein Thrombosis

9,434 Patients Enrolled for Deep Vein Thrombosis

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) NetworkNETWORK

10 Previous Clinical Trials

14,703 Total Patients Enrolled

1 Trials studying Deep Vein Thrombosis

1,500 Patients Enrolled for Deep Vein Thrombosis

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,782,734 Total Patients Enrolled

11 Trials studying Deep Vein Thrombosis

4,089 Patients Enrolled for Deep Vein Thrombosis

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03266783 — Phase 4

Deep Vein Thrombosis Research Study Groups: Apixaban group, Rivaroxaban group

Deep Vein Thrombosis Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT03266783 — Phase 4

Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03266783 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial recruiting participants at present?

"Clinicaltrials.gov displays that this trial, originally created on December 13th 2017, is still accepting candidates. The most recent update was made at the end of March in 2022."

Answered by AI

How many research sites are involved in administering this clinical trial?

"Currently, 16 medical sites are offering participation in this clinical trial. These include Alberta Health Sciences located in Edmonton, St. Paul's Hospital situated in Vancouver and Juravinski Hospital based out of Hamilton; the list is rounded off with an additional 13 locations."

Answered by AI

Is Apixaban being used in other research trials?

"Initially studied in 2015 by the Montreal Heart Institute, apixaban has been subject to a total of 299 trials. Presently, 88 clinical studies are taking place with many centred around Edmonton, British Columbia."

Answered by AI

What medical indications are Apixaban medically used to address?

"Apixaban is frequently utilized to treat venous thromboembolism, but it also has been demonstrated effective in managing chronic coronary artery disease, deep vein thrombosis, and cerebrovascular accident."

Answered by AI

Is this trial the first of its kind?

"As of today, 88 ongoing trials for Apixaban group are taking place in 525 municipalities and 41 countries. The original clinical trial was launched by Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma back in 2015; this Phase 3 drug approval stage included 2180 participants. In the last five years alone, 299 studies have been conducted on Apixaban group."

Answered by AI

Has the Apixaban group received governmental authorization for use?

"Apixaban's efficacy has been established through Phase 4 trials, so it receives a rating of 3 for safety."

Answered by AI

What is the enrollment size of this clinical trial?

"This research requires 2760 participants that meet the prerequisites. Eligibility is not limited to one area, as patients can register from Alberta Health Sciences in Edmonton, British Columbia and St. Paul's Hospital in Vancouver, Ontario."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

2017. "Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03266783.

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