Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter
Conditions
Interventions
None listed
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion 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) 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is as follows: 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) . 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) Timepoint: baseline to EOS | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactSneha Nair
Abbott Healthcare.Pvt. Ltd
Outcome results
None listed