This study is conducted to understand the Anti-Coagulation Effect and Stability Profile in Indian patients with Valvular Heart disease who are prescribed of Nicoumalone (Acenocoumarol) (Vitamin K Antagonist)

Not Applicable

• Conditions: Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter

• Registration Number: CTRI/2021/04/033067
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-19
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

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).

Exclusion Criteria

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is as follows: <br/ ><br>1.To determine the Time in Therapeutic Range (TTR) in patients with VHD and AF or mechanical prosthetic valve replacement or valve repair and AF who are on treatment with Nicoumalone (Acenocoumarol) . <br/ ><br>2.To determine time to achieve desired PT/ INR level in patients with VHD and AF or mechanical prosthetic valve replacement or valve repair and AF who are on treatment with Nicoumalone (Acenocoumarol) <br/ ><br>Timepoint: baseline to EOS

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI