Authorised Therapeutic confirmatory (Phase III) Treatment with a Vitamin K Antagonist due to having a mechanical bileaflet aortic valve replacement.

Low INR to Minimize bleeding with mechanical valves Trial (LIMIT)

EU CTIS ID: 2023-508532-56-00

What this study is testing

Evaluate the safety and efficacy of a common, lower INR range in patients with bileaflet aortic mechanical valves.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Have had a bileaflet mechanical heart valve implant in the aortic position at least 3 months ago (greater than or equal to 3 months)
  • Be at least 18 years of age at the time of enrollment (greater than or equal to 18 years of age)
  • Provide written informed consent (either from the patient or substitute decision-maker)

You likely can't join if

  • Have a second implanted mechanical valve (any position)
  • Lower boundary of planned INR range is less than 2.0
  • Pregnant or expecting to become pregnant during the study follow-up

The study team makes the final eligibility decision.

Where it's taking place

  • Saudi Arabia
  • Australia
  • Korea, Republic of
  • Brazil
  • Russian Federation
  • Botswana
  • Canada
  • South Africa
  • Pakistan
  • Cameroon
  • United Kingdom
  • Chile

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Saudi Arabia; Australia; Korea, Republic of; Brazil; Russian Federation; Botswana and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.