← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after laac

Awards & highlights

ANDES 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.Check my eligibility

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.See study design

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.

ANDES 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.

ANDES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after laac

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

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

Primary outcome measures

Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)

Device thrombosis (efficacy outcome)

Secondary outcome measures

Bleeding events

Device thrombosis

Ischemic events

+2 more

ANDES 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.

0 / 1Eligibility criteria met

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

9,232 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

Frequently Asked Questions

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

Has the FDA sanctioned Anticoagulation therapy for use?

"Anticoagulation therapy has a safety rating of 3 due to it having Phase 4 qualifications; thus confirming its approval."

Answered by AI

What is the upper limit for participants involved in this experiment?

"Affirmative. As per the data found on clinicaltrials.gov, this medical trial is currently seeking applicants and has been since September 1st 2018 when it was first published. The most recent update to its description occured on July 12th 2022. 350 patients are required from one single site for participation in the trials."

Answered by AI

Is this experiment innovative in comparison to the current standard of care?

"Since its initial trial in the year 2005, sponsored by Abbott and involving 15480 participants, Anticoagulation therapy has been heavily studied. The drug received approval after Phase 4 trials concluded successfully and today there are 274 active studies occurring across 65 countries with a total of 1572 cities being involved."

Answered by AI

Is participation in this trial still open to new applicants?

"Affirmative. Clinicaltrials.gov displays that this study is currently recruiting individuals, with the first posting having been on September 1st 2018 and the most recent update occurring July 12th 2022. 350 patients are set to be enrolled across a single medical center."

Answered by AI