Low IRN to Minimize bleeding with mechanical valves Trial (LIMIT) – Vanguard
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.
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.
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
Emilie Belley-Cote, Richard Whitlock