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Anticoagulant

Anticoagulants vs Antiplatelets for Blood Clot Prevention After Heart Procedure (ANDES Trial)

Phase 4
Recruiting
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age≥18 years old
Be older than 18 years old
Must not have
Absolute contraindications for anticoagulation therapy
Major/life-threatening bleeding within the first 24 hrs following LAAC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after laac
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two ways to prevent blood clots around a device used to treat heart problems. One is a short course of a blood thinner called a DOAC. The other is a daily antiplatelet pill.

Who is the study for?
This trial is for adults over 18 who've had a successful transcatheter left atrial appendage closure (LAAC) to prevent strokes. It's not for those with anticoagulation therapy contraindications, past brain hemorrhages, issues with ultrasound heart scans (TEE), severe heart sac swelling or major bleeding post-LAAC, or women at childbearing age not on effective birth control.
What is being tested?
The study compares two treatments after LAAC: short-term anticoagulants like Rivaroxaban and antiplatelet drugs such as low-dose aspirin and Clopidogrel. The goal is to see which better prevents blood clots without causing device thrombosis within the first 8 weeks.
What are the potential side effects?
Anticoagulants can cause bleeding complications, allergic reactions, liver enzyme changes, and potential drug interactions. Antiplatelet drugs may lead to gastrointestinal upset, increased bruising or bleeding risk, rash, and sometimes more serious bleeding events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take blood thinners due to severe side effects or conditions.
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I have not had major bleeding after my heart procedure.
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I cannot take medication to prevent blood clots.
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My kidneys are in end-stage failure.
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I have had a brain bleed in the past.
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I cannot undergo a transesophageal echocardiogram (TEE).
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I have not had a major bleeding event in the last month.
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I developed severe fluid buildup around my heart soon after LAAC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after laac
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after laac for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)
Device thrombosis (efficacy outcome)
Secondary study objectives
Device thrombosis
Ischemic events
Mortality

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Anticoagulation therapyActive Control1 Intervention
Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days.
Group II: Antiplatelet therapyActive Control2 Interventions
Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days.

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor
36 Previous Clinical Trials
9,225 Total Patients Enrolled

Media Library

Rivaroxaban, dabigatran, apixaban, or edoxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03568890 — Phase 4
Blood Clot Research Study Groups: Anticoagulation therapy, Antiplatelet therapy
Blood Clot Clinical Trial 2023: Rivaroxaban, dabigatran, apixaban, or edoxaban Highlights & Side Effects. Trial Name: NCT03568890 — Phase 4
Rivaroxaban, dabigatran, apixaban, or edoxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03568890 — Phase 4
~70 spots leftby Dec 2025
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