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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
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
Perinatal death
Survival free of any stroke
+6 moreOther study objectives
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
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
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Who is running the clinical trial?
Palak Shah, MDLead Sponsor
Abbott Medical DevicesIndustry Sponsor
650 Previous Clinical Trials
411,316 Total Patients Enrolled
126 Trials studying Heart Failure
52,721 Patients Enrolled for Heart Failure
Palak ShahLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently undergoing dialysis for end-stage kidney disease.You have an allergy or cannot take aspirin, warfarin, or apixaban.You have had a stroke, bleeding in your brain, or brain surgery within the last 3 months.You have a history of abnormal blood vessels in your brain or any abnormal growths in your brain.You have a permanent device in your right ventricle to help it pump blood.You have a mechanical heart valve.You have had a blood clot, stroke, or bleeding in your stomach or intestines after having a LVAD (a heart-assist device) implanted.You are taking medications like clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline for blood clot prevention, but not aspirin.You are currently taking certain medications that can interact with the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Apixaban
- Group 2: Warfarin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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