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Anticoagulant

Blood Thinners for Atrial Fibrillation (COBRRA-AF Trial)

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

Confirmed new diagnosis of AF on ECG with an indication to start anticoagulation according to Canadian Cardiovascular Society guidelines

Age ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of the study: 12 months

Awards & highlights

COBRRA-AF Trial Summary

This trial is to compare two blood thinners, rivaroxaban and apixaban, to see which one is more effective in reducing strokes in patients with atrial fibrillation.

Who is the study for?

This trial is for adults over 18 with a new diagnosis of atrial fibrillation confirmed by ECG who need blood thinners according to guidelines. It's not for those with severe kidney issues, active bleeding, mechanical heart valves, other anticoagulation needs, certain liver diseases, or if pregnant/breastfeeding.Check my eligibility

What is being tested?

The study compares the bleeding risks when using two oral blood thinners—Apixaban and Rivaroxaban—in patients with non-valvular atrial fibrillation. It aims to determine which drug has a better balance between benefits and potential harm.See study design

What are the potential side effects?

Potential side effects of Apixaban and Rivaroxaban include bleeding complications such as nosebleeds, heavier periods, bruising easily, persistent bleeding from cuts or gums, red or brown urine and stools indicating internal bleeding.

COBRRA-AF Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have a new diagnosis of atrial fibrillation and need blood thinners.

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I am 18 years old or older.

COBRRA-AF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of the study: 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of the study: 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study: 12 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

The rate of adjudicated clinically relevant bleeding (CRB) events

Secondary outcome measures

Adjudicated Clinically Relevant Non-Major Bleeding events

Hemorrhage

Adjudicated stroke events

+5 more

COBRRA-AF Trial Design

2Treatment groups

Active Control

Group I: Rivaroxaban GroupActive Control1 Intervention

20 mg PO, once daily for 12 months of treatment. A dose reduction* to 15 mg daily will apply to patients with creatinine clearance <50 ml/min. *Patients with AF who are receiving DOAC should have their renal function assessed at baseline and at least annually

Group II: Apixaban groupActive Control1 Intervention

5 mg PO, twice daily for 12 months of treatment. A dose reduction* to 2.5 mg twice daily will apply if patients meet 2 of 3 following criteria: age > 80 years; weight < 60 kg; creatinine >133 micromol/L. *Patients with AF who are receiving DOAC should have their renal function assessed at baseline and at least annually

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,782,676 Total Patients Enrolled

6 Trials studying Atrial Fibrillation

2,795 Patients Enrolled for Atrial Fibrillation

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,450,749 Total Patients Enrolled

20 Trials studying Atrial Fibrillation

646,903 Patients Enrolled for Atrial Fibrillation

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

10 Previous Clinical Trials

14,445 Total Patients Enrolled

Media Library

Apixaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04642430 — Phase 4

Atrial Fibrillation Research Study Groups: Rivaroxaban Group, Apixaban group

Atrial Fibrillation Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT04642430 — Phase 4

Apixaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04642430 — Phase 4

Frequently Asked Questions

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

What health concerns does the Rivaroxaban Group address?

"Rivaroxaban Group is frequently prescribed to treat venous thromboembolism and other medical issues such as chronic coronary artery disease, deep vein thrombosis, or cerebrovascular accident."

Answered by AI

Are there current opportunities for people to enter this clinical study?

"Affirmative. According to information provided on clinicaltrials.gov, this research endeavour is still searching for volunteers and was initially published on July 6th 2021 with its most recent update occurring on March 14th 2022. This study has a need of 3018 patients from one single medical centre."

Answered by AI

Is this trial a pioneering endeavor in its particular field?

"Research on the Rivaroxaban Group has been ongoing ever since 2015, when Bayer Healthcare Pharmaceuticals/Bayer Schering Pharma sponsored a pioneering trial with 2180 participants. After achieving Phase 3 drug approval following this initial study, 88 active clinical trials have opened up across 41 countries and 525 cities."

Answered by AI

Has the Rivaroxaban Group been given authorization by the FDA?

"Rivaroxaban Group has been approved, justifying its safety score of 3 on our 1-3 scale."

Answered by AI

How many individuals are engaged in this clinical investigation?

"Affirmative, the information hosted on clinicaltrials.gov demonstrates that recruitment for this medical study is ongoing. This research was launched on July 6th 2021 and last edited March 14th 2022; 3018 patients are needed across 1 trial location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation

2021. "COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04642430.

All > Afib > Apixaban