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Antiplatelet Agent

Anti-Thrombotic Strategies for Blood Clot Prevention (FADE-DRT Trial)

Phase 4

Waitlist Available

Research Sponsored by Texas Cardiac Arrhythmia Research Foundation

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

FADE-DRT Trial Summary

This trial compared three different blood-thinning strategies after percutaneous left atrial appendage occlusion with a Watchman FLX LAAC device.

Who is the study for?

This trial is for men and women over 18 who've had a successful procedure to close off a part of the heart (LAA occlusion) without complications. It's aimed at those who can't take long-term blood thinners and have a history of irregular heartbeat. Participants must not be pregnant, breastfeeding, or have life-threatening conditions.Check my eligibility

What is being tested?

The study compares three anti-clotting strategies after LAA closure with Watchman FLX device: ASA plus Clopidogrel (common blood thinners), genetically-tailored medication, and half-dose novel oral anticoagulants (new type of blood thinner).See study design

What are the potential side effects?

Potential side effects include bleeding risks, allergic reactions to medications, possible genetic testing risks like privacy concerns, and varying responses to reduced doses of new anticoagulants.

FADE-DRT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite of Stroke, Systemic Embolism, and Device-related Thrombosis

Incidence of Major Bleeding Events

Secondary outcome measures

Incidence of Minor Bleeding Events

FADE-DRT Trial Design

3Treatment groups

Active Control

Group I: Genetic-Tailored AntiThrombotic StrategyActive Control1 Intervention

OAC for 6 weeks followed by DAPT (clopidogrel responders) or aspirin plus half-dose OAC (clopidogrel non-responders) until 6 month-follow-up, then aspirin alone

Group II: Half-Dose NOACActive Control1 Intervention

Half Dose of Novel OAC

Group III: Standard Antithrombotic TherapyActive Control1 Intervention

OAC for 6 weeks followed by DAPT until 6 month-follow-up, then aspirin alone

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Texas Cardiac Arrhythmia Research FoundationLead Sponsor

37 Previous Clinical Trials

13,020 Total Patients Enrolled

Media Library

ASA plus Clopidogrel (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04502017 — Phase 4

Left Atrial Appendage Occlusion Research Study Groups: Genetic-Tailored AntiThrombotic Strategy, Half-Dose NOAC, Standard Antithrombotic Therapy

Left Atrial Appendage Occlusion Clinical Trial 2023: ASA plus Clopidogrel Highlights & Side Effects. Trial Name: NCT04502017 — Phase 4

ASA plus Clopidogrel (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502017 — Phase 4

Frequently Asked Questions

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

What prior research exists into Genetic-Tailored AntiThrombotic Strategy?

"Currently, 55 clinical trials are investigating Genetic-Tailored AntiThrombotic Strategy with 14 in Phase 3. Beijing is one of the many sites hosting these studies; however, there exist 797 other locations conducting research concerning this issue."

Answered by AI

For what conditions is Genetic-Tailored AntiThrombotic Strategy most frequently recommended?

"Genetic-Tailored AntiThrombotic Strategy is frequently employed to defend against cardiovascular events. Unstable angina pectoris, acute chest syndrome and those eligible for thrombolytic therapy are all conditions that can be alleviated by this novel treatment strategy."

Answered by AI

Is the current research recruiting participants?

"Affirmative. Clinicaltrials.gov data implies that this clinical investigation is presently enrolling participants, having first been posted on August 5th 2020 and recently updated on the same date. A total of 360 patients from 1 site have to be recruited for participation in the trial."

Answered by AI

Has the Genetic-Tailored AntiThrombotic Strategy obtained regulatory clearance from the FDA?

"Drawing on the data from our internal team, we assign a score of 3 to Genetic-Tailored AntiThrombotic Strategy due to it being in Phase 4 clinical trials which is indicative of its approval."

Answered by AI

What is the size of the cohort participating in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting participants and was first published on August 5th 2020 with a recent update also made on the same day. The study requires 360 patients from one single site in order for it to be complete."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion

Andrea Natale 2020. "Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502017.

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