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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

Must not have

Renal insufficiency (creatinine > 1.5 mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is impaired with creatinine levels above 1.5 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2016 Phase 3 trial • 2199 Patients • NCT02072434

Atrial fibrillation

International normalised ratio increased

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Warfarin

Edoxaban

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met