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Anticoagulant
Warfarin for Prosthetic Heart Valve Clots (RESOLVE Trial)
N/A
Recruiting
Led By Raj Makkar, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
RESOLVE Trial Summary
This trial will use different types of imaging to look at how well different types of valves work. It will also look at whether taking blood-thinners helps to reduce early valve problems.
Who is the study for?
This trial is for adults over 18 who have had a bioprosthetic aortic valve placed at least two days before joining. They must be able to give informed consent and follow the study's procedures. People with kidney issues (creatinine > 1.5 mg/dL) or allergies to iodinated contrast agents cannot participate.Check my eligibility
What is being tested?
The study is testing how well Warfarin, an anticoagulant medication, can resolve blood clots on artificial heart valves. It involves detailed imaging to check the valves' condition before and after treatment.See study design
What are the potential side effects?
Warfarin may cause bleeding problems, bruising easily, and in rare cases could lead to serious bleeding events. Patients are closely monitored for these side effects during the trial.
RESOLVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
RESOLVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of patients with structural/functional abnormalities of bioprosthetic valves
Other outcome measures
Percentage of patients with resolution of bioprosthetic valve thrombotic lesions with anticoagulation
Side effects data
From 2016 Phase 3 trial • 2199 Patients • NCT020724345%
Atrial fibrillation
1%
International normalised ratio increased
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Warfarin
Edoxaban
RESOLVE Trial Design
1Treatment groups
Experimental Treatment
Group I: Pre-existing bioprosthetic aortic valveExperimental Treatment1 Intervention
Patients with a history of surgical or transcatheter valve replacement with bioprosthetic valves undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy with Vitamin K antagonists (Warfarin) for 3 months with goal INR 2-3, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Warfarin
2017
Completed Phase 4
~248220
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
161,863 Total Patients Enrolled
Raj Makkar, MDPrincipal Investigator - Cedars-Sinai Medical Center, Los Angeles, California
B.J. Medical College (Medical School)
Cedars-Sinai Medical Center (Residency)
3 Previous Clinical Trials
1,321 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is impaired with creatinine levels above 1.5 mg/dL.I am 18 years old or older.You are allergic to iodine-based contrast agents.I had a heart valve replacement at least 2 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-existing bioprosthetic aortic valve
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what ailment is Warfarin most regularly prescribed?
"Warfarin can be administered to treat thromboembolism, forestall venous thrombosis and manage cerebrovascular accident."
Answered by AI
What is the current capacity of this medical research program?
"Indeed, clinicaltrials.gov confirms that the trial is actively recruiting participants who meet its criteria. This investigation was originally posted on December 1st 2014 and has since been updated on January 6th 2022. 3000 people are required to join this study at a single site."
Answered by AI
Have any preceding investigations been performed with Warfarin?
"At present, 26 Warfarin-related clinical trials are currently running worldwide. 9 of these studies have entered Phase 3 testing and can be found in 379 different medical centers located primarily in Montreal, Quebec."
Answered by AI
Is this trial open to new participants?
"Affirmative, the information hosted on clinicaltrials.gov reveals that this research study is actively recruiting participants. Initially posted on December 1st 2014 and recently edited as of January 6th 2022, 3000 patients must be recruited from a single site for completion."
Answered by AI
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