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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 from enrollment to end of treatment at 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two blood-thinning medications, apixaban and warfarin, in patients with a specific heart device called HeartMate 3 LVAD. These medications help prevent blood clots, which is crucial for these patients. Apixaban has been shown to be a safe and effective alternative to warfarin for stroke prevention in various patient populations, including those with atrial fibrillation.

Eligible Conditions
  • Heart Failure
  • Congestive Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment at 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)
Secondary study objectives
All-cause Mortality
Cardiovascular Mortality
Survival Free of Any Stroke
+6 more
Other study objectives
Freedom From Death or Hemocompatibility Related Adverse Events Evaluated in Subgroups of Patients Within 3 Months of Implant Versus Greater Than 3 Months From LVAD Implant

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
LVAD implant
2021
Completed Phase 2
~30
Apixaban
2011
Completed Phase 4
~132290

Find a Location

Who is running the clinical trial?

Palak Shah, MDLead Sponsor
Abbott Medical DevicesIndustry Sponsor
652 Previous Clinical Trials
416,807 Total Patients Enrolled
126 Trials studying Heart Failure
52,721 Patients Enrolled for Heart Failure
Palak ShahLead Sponsor
Palak Shah, MD, MSPrincipal InvestigatorInova Health Care Services

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
~7 spots leftby Dec 2025
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