FindTrial
Sign In

Registry of Vitamin K Antagonists in Thromboembolic Disorders

ThromboemboliC DisOrders - A Registry oF Newly DIagnoseD PatiENts on Oral AntiCoagulation TrEatment (Vitamin K Antagonists): The CO(N)FIDENCE Registry - The Confidence Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2014/11/005224
Enrollment
800
Registered
2014-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Newly diagnosed patients with thromboembolic disorders and prescribed with oral vitamin K antagonists in real time clinical practice

Interventions

None listed

Sponsors

Abbott Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1.Clinical and demographic characteristics of thromboembolic patients. 2. Dose and duration of VKA treatment in thromboembolism. 3. Use of different VKA treatments (grouped on the basis of thromboembolic disorders)Timepoint: At end of study (12 months)—

Secondary

MeasureTime frame
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)—

Countries

India

Contacts

Public ContactDr Abhijit Trailokya

Abbott Healthcare Private Limited

abhijit.trailokya@abbott.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026