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Anticoagulant

Discontinuing Anticoagulants for Atrial Fibrillation (DESTINATION Trial)

Phase < 1

Waitlist Available

Research Sponsored by China National Center for Cardiovascular Diseases

Eligibility Criteria Checklist

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

Must have

Diagnosed paroxysmal, persistent, or longstanding persistent AF

Successful procedure with no recurrence within 3 months of ablation using a cooled tip RF-, laser- or cryo-balloon-catheter

Must not have

Valvular AF (moderate-severe mitral insufficiency; relevant mitral stenosis with a mean pressure gradient >5mmHg)

Prior AF ablation (including surgical ablation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Awards & highlights

No Placebo-Only Group

Summary

"This trial is looking at whether patients need to keep taking blood thinners after atrial fibrillation treatment. Current guidelines say to keep taking them even after treatment, but this study wants to see if that

Who is the study for?

This trial is for patients with atrial fibrillation who've had a successful catheter ablation and have been free of AF recurrence for 6-12 months. They must be willing to use smart wearable monitors and participate in the study for 24 months.

What is being tested?

The DESTINATION Study is testing if stopping anticoagulant drugs after successful catheter ablation reduces bleeding without increasing stroke risk. Patients are randomly chosen to either continue or stop taking these blood thinners.

What are the potential side effects?

Continuing anticoagulants may increase the risk of bleeding, while discontinuing them could raise the chance of stroke due to potential clot formation. Wearable monitor usage has minimal side effects.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a form of irregular heartbeat.

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I had a successful ablation with no issues for 3 months.

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I have had no complications from recent medical procedures.

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I am 18 years old or older.

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I am a male with a stroke risk score of 1 or more, or a female with a score of 2 or more.

Exclusion Criteria

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

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I have a serious heart valve condition.

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I have had a procedure to correct atrial fibrillation.

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I am undergoing or have undergone a procedure to remove or destroy tissue.

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I have a blood clot in my heart's left side.

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I am a woman of childbearing age and I refuse to use birth control during the study.

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I need long-term blood thinners for a condition that is not related to irregular heartbeats.

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I have not had a recent heart attack, severe heart failure, or conditions increasing my risk of blood clots.

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I cannot take blood thinners due to a risk of bleeding.

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I have not taken strong CYP3A drugs in the last 4 days.

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I have not had a stroke or brain bleed in the last 6 months.

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I have had surgery on the left side of my heart.

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I cannot take blood thinners or antiplatelet medications due to health reasons.

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I am over 85 years old.

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I was born with a heart defect.

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I understand and can follow the study's requirements.

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I cannot or do not want to give consent for treatment.

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My atrial fibrillation is caused by a treatable condition like uncontrolled thyroid disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite outcome consisting of thromboembolic events and clinically significant bleeding events

Secondary study objectives

AF Recurrence Rate

Complication rates

Major Adverse Cardiovascular Events (MACE)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: off-OACExperimental Treatment2 Interventions

In the off-OAC, involving the discontinuation of OAC therapy, patients had their OAC treatment terminated post-randomization, and no placebo medication was administered as a substitute.

Group II: on-OACActive Control2 Interventions

In the cohort assigned to the "on-OAC" arm, which entails the continuation of Oral Anticoagulant (OAC) therapy, patients were prescribed Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), specifically dabigatran, rivaroxaban, or apixaban, for a duration of 24 months following randomization. The dosing regimen was as follows: (1) Standard dosage included rivaroxaban at 20mg daily, apixaban at 5mg twice daily, and dabigatran at 150mg twice daily. (2) Reduced dosage was administered in cases where patients were aged over 75 years, had a body weight less than 50kg, or exhibited creatinine clearance below 50ml/min.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Catheter Ablation

2016

Completed Phase 4

~3920

0 / 22Eligibility criteria met