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

NCT02610153 | Completed

• 1 other identifier: 17943
• Study Type: observational
• Target: 1,013
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Baseline thromboembolic risk based on the CHADS2 scale

  Baseline

• Baseline thromboembolic risk based on the CHA2DS2-VASc scale

  Baseline

• Baseline haemorrhagic risk based on the HAS-BLED scale

  Baseline

• Changes in INR time in therapeutic range

  Up to 24 months

• Patient preferences with regard to anticoagulant treatment based on patients' questionnaires

  Up to 12 months

Study Arms (1)

Cohort 1

Adult patients, diagnosed with no-valvular atrial fibrillation and who have recently initiated or are going to initiate VKA treatment, that attend the Cardiology Units

Drug: Vitamin K Antagonist

Interventions

Vitamin K Antagonist DRUG

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).

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with non-valvular atrial fibrillation who are going to start vitamine K antagonist treatment or have started over the previous two months and that attend the Cardiology Units at Spanish hospitals (as outpatients).

You may qualify if:

• 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.

You may not qualify if:

• Patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty).
• Patients with a life expectancy of less than 13 months.
• Patients who are participating in a clinical trial.
• Patients receiving double antiplatelet therapy.

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

acarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 20, 2015
• Study Start: October 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: March 15, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

ES (1)