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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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All Cause Mortality
All Stroke
At least moderately restricted leaflet motion (RELM)
+4 moreSecondary outcome measures
Acute kidney injury
All stroke
All-cause mortality
+6 moreTrial 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
~5790
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Who is running the clinical trial?
Medstar Health Research InstituteLead Sponsor
189 Previous Clinical Trials
115,449 Total Patients Enrolled
Ron S Waksman, MDPrincipal InvestigatorMedStar Cardiovascular Research Network
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are opportunities for enrollment currently available for this research endeavor?
"According to clinicaltrials.gov, the start date for this trial was July 5th 2018 and it has not been updated since January 3rd 2022; thus indicating that no further individuals are required at present. Fortunately, there are 161 other trials actively recruiting patients now."
Answered by AI
In what locales can patients access this medical trial?
"This medical research project is being conducted at 7 different sites, located in Stony Brook, San Diego and Richmond among other cities. It is suggested to pick the closest site available in order to reduce travelling time if one chooses to take part."
Answered by AI
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