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Procedure

Warfarin plus Aspirin for Aortic Stenosis

N/A
Waitlist Available
Led By Ron S Waksman, MD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will have 100 subjects in each treatment arm, and up to 100 subjects in the registry arm.

Eligible Conditions
  • Aortic Stenosis

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All Stroke
Hemodynamic dysfunction
Secondary study objectives
All stroke
VARC-2 device success

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Warfarin plus AspirinExperimental Treatment2 Interventions
100 subjects will be randomized electronically through the Electronic Data Capture System in a 1:1 fashion to warfarin plus low dose aspirin for 30-45 days
Group II: Registry ArmExperimental Treatment1 Intervention
Upto an additional 100 subjects with preexisting indication for anti coagulation (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism) or who are not eligible for randomization after TAVR due to development of a new indication for anti coagulation will be enrolled in the registry arm of the study.
Group III: Aspirin MonotherapyExperimental Treatment2 Interventions
100 subjects will be randomized electronically through the Electronic Data Capture System in a 1:1 fashion to low dose aspirin monotherapy for 30-45 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVR
2017
N/A
~6010

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
195 Previous Clinical Trials
183,035 Total Patients Enrolled
Ron S Waksman, MDPrincipal InvestigatorMedStar Cardiovascular Research Network
~17 spots leftby Nov 2025
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