Indian Experience in a Real World Clinical Setting to Understand the Anti-Coagulation Effect Stability Profile of Nicoumalone (Acenocoumarol) (Vitamin K Antagonist) in Valvular Heart disease - Dependable Study - DEPENDABLE STUDY

Abbott Healthcare Pvt Ltd0 sites112 target enrollmentStarted: TBDLast updated: October 17, 2022

Trial Snapshot

No summary available.

•1.Patients of either sex aged between 18 and 70 years.
•2.Patients put on treatment with Nicoumalone (Acenocoumarol) within the last 1 year (data capture) either of the following indications
•a.VHD with AF
•b.Mechanical prosthetic valve replacement
•c.Post-Valve repair with AF
•3.Patient who have achieved desired PT/INR range:
•VHD and AF:
•a.ACC/AHA recommends VKA therapy with a target INR of 2 to 3 .
•Mechanical Heart Valves: ACCP and IACTS guidelines recommends VKA therapy with a target
•b.Mechanical aortic valve, VKA therapy with a target INR of 2.5 (range 2.0 to 3.0)
•c.Mechanical mitral valve, VKA therapy with a target INR of 3.0 (range 2.5 to 3.5)
•d.Mechanical valves in both the aortic and mitral position, a target INR of 3.0 (range 2.5 to 3.5)
•Valve repair and AF:
•a.Target INR of 2 to 3
•4.Patients willing to sign the patient authorization form (PAF).

•1.Patients with renal impairment.
•2.Patients with significant liver diseases (i.e. cirrhosis).
•3.Patients with active or high-risk bleeding.
•4.Patients not willing to sign PAF.
•5.Patients with anticipated non-adherence to Nicoumalone (Acenocoumarol) treatment.
•6.Patients with alcohol abuse.
•7.Patients allergic or intolerant to Nicoumalone (Acenocoumarol)

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