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Clinical Trials/CTRI/2021/04/033067
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

Abbott Healthcare Pvt Ltd0 sites112 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
May 19, 2022
Last Updated
3 years ago
Study Type
Observational

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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