None listed
Conditions
Interventions
Intervention1: Not Applicable as it is a Real World Evidence Study: Not Applicable as it is a Real World Evidence Study
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Interven
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study 1 Adult patients of either sex, aged greater than equal to 18 to less than equal to 80 years 2 Patients with a recent diagnosis of valvular heart disease VHD who have been initiated on treatment with oral Vitamin K Antagonists VKAs acenocoumarol or warfarin, as per the treating physicians clinical judgment, for one of the following indications. a. VHD Patients Undergoing Valve Replacement Surgery. b. Patient undergoing valve repair procedures started on VKAs post intervention. 3 Patients willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study 1. Patients with renal impairment & not suited for VKA treatment as per investigators judgement 2. Patients with significant liver disease i.e. cirrhosis and not suited for VKA treatment as per investigators judgement 3. Patients with active or high-risk bleeding 4. Patients not willing to sign PAF 5. Patients with alcohol abuse 6. Patients who are allergic or intolerant to Acenocoumarol and Warfarin. 7. Pregnancy or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Descriptive analysis of clinical profile, including disease duration, aetiology and type of valvular heart disease VHD, type of valve prosthesis 2. Descriptive analysis of patient demographics, including age, gender, socioeconomic status. 3. Assessment of oral vitamin K antagonist VKA utilization patterns, including proportion of patients receiving warfarin and acenocoumarolTimepoint: Baseline, Month 1, 3 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of Major Adverse Cardiovascular Events MACE events during the study period CV death, nonfatal MI, Stroke. 2. Number of thromboembolic events & all cause mortality apart from MACE during the study period. 3. Number of hospitalization episodes for thromboembolism valve thrombosis during the study period. 4. Number of patients tested for genetic polymorphisms eg VKORC1 & CYP2C9 while on anticoagulation data available as per clinical practice. 5. Percentage of patients in TTR between Acenocoumarol & Warfarin groups from baseline to end of study. 6. Concomitant medications prescribed from baseline to end of study.Timepoint: Baseline Month 1, 3 & 6 | — |
Countries
India
Contacts
Public ContactDr Somesh Bolegave
Abbott Healthcare Private Limited
Outcome results
None listed