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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

Must not have

Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to: active bleeding, history of mechanical valve, other indication for anticoagulation (e.g. mechanical valves, venous thrombosis), dual antiplatelet agent use, known liver disease with coagulopathy, use of contraindicated medications (strong inducers/inhibitors of CYP 3A4/5, P-glycoprotein), pregnancy or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of the study: 12 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

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.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can safely take blood thinners like apixaban or rivaroxaban without any health risks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The rate of adjudicated clinically relevant bleeding (CRB) events

Secondary study objectives

Medication adherence

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met