Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies

Atrial Fibrillation Clinical Trial

— SULTAN  

Official title:

A Prospective Observational Study Assessing the Management of Anticoagulation With Vitamin K Antagonists in Patients With Nonvalvular Atrial Fibrillation Treated in Cardiology Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610153
• Other study ID #: 17943
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin K antagonist (VKA) treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1013
• Est. completion date: March 15, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years.

• Patients with a diagnosis of nonvalvular atrial fibrillation according to the criteria of the Spanish Agency of Medicines and Medical Devices (AEMPS) (2013) who are treated in cardiology practices.

• Patients about to start treatment with a vitamin K antagonist or who are in the first two months of treatment.

• Patients for whom access to at least 80% of INR tests performed during treatment with vitamin K antagonists is expected to be available.

• Patients with the mental and physical capacity to complete the study questionnaires and give their informed consent to participate in the study.

Exclusion Criteria:

• Patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty).

• Patients hospitalised at the time of inclusion in the study.

• Patients with a life expectancy of less than 13 months.

• Patients who are participating in a clinical trial.

• Patients receiving double antiplatelet therapy.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Vitamin K Antagonist
The vitamin K antagonists exert their anticoagulant effect through inhibition of the enzyme complex of vitamin K epoxide reductase subunit 1 with subsequent reduction of the gamma-carboxylation of certain glutamic acid molecules endpoints located on factors coagulation II (prothrombin), VII, IX and X and protein C or its cofactor protein S. This gamma-carboxylation has a significant bearing on the interaction of coagulation factors referenced with calcium ions. Without this reaction, blood clotting cannot be initiated. The dose must be adjusted to each patient at baseline and after regular basis, since the sensitivity to anticoagulants varies between individuals and can also vary throughout the treatment. For this, the Prothrombin Time (PT) is used and standardized ratio called International Normalised Ratio (INR).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Normalized Ratio (INR) Time in Therapeutic Range (TTR)	Percentage of time within an INR range of 2-3 estimated using the Rosendaal method	Up to 24 months
Secondary	Baseline thromboembolic risk based on the CHADS2 scale	CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke	Baseline
Secondary	Baseline thromboembolic risk based on the CHA2DS2-VASc scale	CHA2DS2-VASc:Cardiac failure, Hypertension, Age =75, Diabetes, Stroke -Vascular disease, Age and sex category	Baseline
Secondary	Baseline haemorrhagic risk based on the HAS-BLED scale	HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol	Baseline
Secondary	Changes in INR time in therapeutic range	INR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal method	Up to 24 months
Secondary	Patient preferences with regard to anticoagulant treatment based on patients' questionnaires		Up to 12 months
Secondary	Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)		Up to 12 months
Secondary	Adherence to the anticoagulant treatment: Morisky-Green test		Up to 12 months
Secondary	Number and type of visits by patients to health professionals related to their anticoagulant treatment		Up to 12 months
Secondary	Number of patients using anticoagulant treatment strategies	Strategies: patients continuing vitamin K antagonists, patients with changes/adjustments to the dose of vitamin K antagonists and patients whose treatment is changed to direct action oral anticoagulants	Up to 24 months
Secondary	Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning report		Up to 24 months
Secondary	Number of thromboembolic events in patients with inadequate anticoagulation management		Up to 24 months
Secondary	Number of haemorrhagic events in patients with inadequate anticoagulation management		Up to 24 months

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