CTRI/2021/04/033067
Other
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter
- Sponsor
- Abbott Healthcare Pvt Ltd
- Enrollment
- 112
- Status
- Other
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\)
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)
Outcomes
Primary Outcomes
Not specified
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