Apixaban for Heart Failure

Inova Fairfax Medical Campus, Falls Church, VA
Heart FailureApixaban - Drug
Eligibility
18 - 99
All Sexes

Study Summary

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 24 weeks

24 weeks
All-cause mortality
Perinatal death
Freedom from death or hemocompatibility related adverse events (stroke, device thrombosis, bleeding, and arterial non-CNS thromboembolism)
Freedom from death or hemocompatibility related adverse events (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)
Survival free of any stroke
Survival free of aortic root thrombus
Survival free of device thrombosis
Survival free of gastrointestinal bleeding
Survival free of hemorrhagic stroke
Survival free of ischemic stroke
Survival free of major non-gastrointestinal bleeding
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

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Warfarin
1 of 2
Apixaban
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Apixaban · No Placebo Group · Phase 2

ApixabanExperimental Group · 2 Interventions: Apixaban, LVAD implant · Intervention Types: Drug, Device
WarfarinActiveComparator Group · 2 Interventions: Warfarin, LVAD implant · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Abbott Medical DevicesIndustry Sponsor
604 Previous Clinical Trials
365,867 Total Patients Enrolled
122 Trials studying Heart Failure
48,968 Patients Enrolled for Heart Failure
Palak Shah, MDLead Sponsor
Palak ShahLead Sponsor
Palak Shah, MD, MSPrincipal InvestigatorInova Health Care Services

Eligibility Criteria

Age 18 - 99 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a HeartMate 3 LVAD device implanted in your heart.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.