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Research

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LIMIT

Official Title

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

Status

Ongoing

Overview

Assess the feasibility of a large trial to evaluate the safety and efficacy of a common, lower INR target range in patients with bileaflet aortic mechanical valves.
Full trial: Evaluate the safety and efficacy of a common, lower INR target range in patients with bileaflet aortic mechanical valves.

Study Design

A vanguard prospective, randomized, open-label, blinded end-point (PROBE), multicenter clinical trial. The intervention of interest is a low INR target range (1.5 to 2.5) compared to the current practice as per guideline recommendations.

Primary Endpoint

Vanguard phase outcomes: feasibility of recruiting 200 subjects over 1 year at 1 centre.

Full trial outcomes:
1) Major bleeding over follow-up (primary)
2) All thrombosis/thromboembolism: ischemic stroke, systemic thromboembolism and valve thrombosis (most important secondary)
3) All-cause mortality
4) All bleeding
5) Minor bleeding
6) All Stroke (ischemic and hemorrhagic)
7) Ischemic Stroke
8) Hemorrhagic Stroke
9) Systemic thromboembolism
10) Valve thrombosis
11) Time in therapeutic range

Number of Patients

200

Number of Sites

5

Number of Countries

1

Study Period

2019-2020

Principal Investigator

Emilie Belley-Cote, Richard Whitlock

Program Manager

Shirley Pettit

Research Coordinator

Amber Good