Registry of Vitamin K Antagonists in Thromboembolic Disorders
- 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
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
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
Name Time Method 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
Name Time Method 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)