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Registry of Vitamin K Antagonists in Thromboembolic Disorders

Not Applicable
Conditions
Health Condition 1: null- Newly diagnosed patients with thromboembolic disorders and prescribed with oral vitamin K antagonists in real time clinical practice
Registration Number
CTRI/2014/11/005224
Lead Sponsor
Abbott Healthcare Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
800
Inclusion Criteria

1.Patients of either sex aged between 18 and 80 years

2.Newly diagnosed patients prescribed with oral VKA alone or in combination with other antithrombotics (eg., Heparin, Aspirin, Clopidogrel) for:

i.Stroke prevention in atrial fibrillation (SPAF).

ii. Venous thromboembolism- VTE (DVT & PE).

iii. Valvular heart disease.

iv. Post prosthetic heart valve surgery.

3. Patients willing to sign the patient authorization form

Exclusion Criteria

The patients with following condition/disorder will be excluded from the Registry:

1.Renal impairment.

2.Significant liver diseases (i.e. cirrhosis).

3.Active or high-risk bleeding.

4.Patients with anticipated non-adherence to VKA treatment; alcohol abuse; and allergic or intolerant to VKA.

5.Pregnant women or those planning to become pregnant.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Clinical and demographic characteristics of thromboembolic patients. <br/ ><br>2. Dose and duration of VKA treatment in thromboembolism. <br/ ><br>3. Use of different VKA treatments (grouped on the basis of thromboembolic disorders)Timepoint: At end of study (12 months)
Secondary Outcome Measures
NameTimeMethod
Change in risk index scores over the period of assessment in patients where it was recordedTimepoint: At end of study (12 months);Duration for which patients remain in the required PT-INR therapeutic range.Timepoint: At end of study (12 months);Incidence of adverse drug reactions over a period of 1 yearTimepoint: At end of study (12 months);Incidence of thromboembolism during one year of VKA treatment.Timepoint: At end of study (12 months);Mean change in PT INR values and frequency of VKA dose change over a period of 1 yearTimepoint: At end of study (12 months);Number of patients within PT-INR therapeutic range in 1 year of treatment.Timepoint: At end of study (12 months);Percentage of patients who remain stable for at least 2 weeks in the required PT-INR therapeutic rangeTimepoint: At end of study (12 months);Time and dosage of anticoagulants required to achieve stable PT-INR valuesTimepoint: At end of study (12 months)
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