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Direct Oral Anticoagulant

Apixaban for Heart Failure with LVAD Implant (DOAC LVAD Trial)

Phase 2
Waitlist Available
Led By Palak Shah, MD, MS
Research Sponsored by Palak Shah, MD
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 24 weeks
Awards & highlights

DOAC LVAD Trial Summary

This trial is testing whether the drug apixaban is better than warfarin for people with a certain kind of heart condition.

DOAC LVAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from death or hemocompatibility related adverse events (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)
Secondary outcome measures
All-cause mortality
Perinatal death
Survival free of any stroke
+6 more
Other outcome measures
The rate of primary and will be evaluated in subgroups of patients within 3 months of implant versus greater than 3 months from LVAD implant

DOAC LVAD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ApixabanExperimental Treatment2 Interventions
LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily.
Group II: WarfarinActive Control2 Interventions
LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
2011
Completed Phase 4
~132290
LVAD implant
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Palak Shah, MDLead Sponsor
Abbott Medical DevicesIndustry Sponsor
638 Previous Clinical Trials
404,451 Total Patients Enrolled
124 Trials studying Heart Failure
51,952 Patients Enrolled for Heart Failure
Palak ShahLead Sponsor

Media Library

Apixaban (Direct Oral Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04865978 — Phase 2
Heart Failure Research Study Groups: Apixaban, Warfarin
Heart Failure Clinical Trial 2023: Apixaban Highlights & Side Effects. Trial Name: NCT04865978 — Phase 2
Apixaban (Direct Oral Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04865978 — Phase 2

Frequently Asked Questions

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

Are there other instances in which Apixaban has been used for research purposes?

"At the moment, there are a total of 69 clinical trials in progress that involve Apixaban. 23 of these live studies are classified as Phase 3 research. The majority of the Apixaban clinical trials are based in Montreal, but there are 1,446 locations worldwide where these medical studies are taking place."

Answered by AI

Has Apixaban been cleared by the FDA?

"While there is some data indicating Apixaban's safety, it only received a score of 2 because this is a Phase 2 trial and thus there is no clinical evidence yet affirming its efficacy."

Answered by AI

Are there specific inclusion or exclusion criteria for this research study?

"This particular clinical trial has room for 40 participants that have heart failure and are between 18-99 years old. Additionally, these applicants must also have had a HeartMate 3 LVAD implanted."

Answered by AI

What benefits does this experiment hope to bring patients?

"The success of this clinical trial, which will be assessed over the course of 24 weeks, is measured by a patient's freedom from death or any negative events related to hemocompatibility (such as stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism). Additionally, secondary outcomes include Survival free of aortic root thrombus and hemorrhagic stroke. Lastly, all-cause mortality will be compared between each study arm."

Answered by AI

How many guinea pigs are a part of this test?

"That is correct. According to the clinicaltrials.gov website, this trial is currently looking for 40 patients at 1 location. The original posting was on December 14th, 2021 and there have been no updates since February 21st, 2022."

Answered by AI

Does this research still have positions available for participants?

"This clinical trial, which was first posted on December 14th 2021, is still recruiting participants according to the latest update on February 21st 2022."

Answered by AI

Are adults outside of the age limit of 20 years old able to participate in this research?

"The age requirements to participate in this clinical trial are between 18-99 years old."

Answered by AI

What is the most common reason that doctors prescribe Apixaban?

"Apixaban is frequently used to dissolve deep vein thrombosis, but it can also be employed to ameliorate cerebrovascular accident, systemic embolism, and myocardial infarction."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Palak Shah 2021. "Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04865978.
~9 spots leftby Apr 2025
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