Αdherence and Persistence to Oral Anticoagulation in ΑF Patients With Previous Ischemic Stroke

NCT ID: NCT03463421

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2020-02-29

Brief Summary

The aims of this project are to:

1. investigate the adherence and persistence to anticoagulation (and in specific, to VKAs and NOACs) in AF patients with previous ischemic stroke;

2. identify predictors of poor adherence and persistence and

3. assess whether the SAMe-TT2R2 score predicts adherence and persistence to anticoagulation

Detailed Description

Patients with ischemic stroke and atrial fibrillation (AF) have a high risk of stroke recurrence, which is the highest among all other pathogenetic subtypes of stroke. This risk is substantially reduced with anticoagulant treatment. For many decades, vitamin-K antagonists (VKA) were the only anticoagulant choice for these patients. However, a number of limitations such as narrow therapeutic window, need for frequent INR measurements and consequent dose adjustments, risk of haemorrhagic complications, food-drug and drug-drug interactions, and others, have undermined the use of anticoagulation by both patients and physicians with apparent influence on the risk of stroke recurrence. During the last decade, four non-vitamin K antagonist oral anticoagulants (NOAC) have been successfully introduced and showed superior safety and efficacy profile than VKAs, more convenient dosing schemes (i.e. no need for adjustments) and minimum interactions with food and drugs. These advantages of NOACs vs. VKAs may have obvious implications to patient adherence to treatment and, consequently, to the efficacy of secondary stroke prevention. Nevertheless, there are only very scarce data available yet that the adherence and persistence to NOACs is higher than the adherence and persistence to VKAs in the specific population of patients with ischemic stroke and atrial fibrillation.

Recently, the SAMe-TT2R2 score has been introduced as a means to identify those AF patients who have inadequate quality of anticoagulation with VKAs expressed as Time within Therapeutic Range (TTR)5. In specific, VKA-anticoagulated AF patients with a SAMe-TT2R2 score of 0-2 are expected to have a TTR >65%, whereas patients with a score of >2 are expected to have lower TTR levels. In this context, one could hypothesize that increased SAMe-TT2R2 score may be associated with inadequate adherence and persistence to VKAs. Other parameters associated with inadequate adherence and persistence in the general AF population include education, employment, social status, and cognitive function. However, this is not well investigated in the specific population of patients with previous stroke where other conditions such as age and functional neurological status may also play an important role in adherence and persistence.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Previous ischemic stroke
• Atrial fibrillation
• Age >18 years
• Informed consent

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

George Ntaios

MD, MSc (ESO Stroke Medicine), PhD, FESO, Assistant Professor of Internal Medicine, Medical School, University of Thessaly, Larissa University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Ntaios, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical School, University of Thessaly, Larissa University Hospital

Locations

Department of Neurology, Helsinki University Hospital, Helsinki, FinlandHelsinki University Hospital

Helsinki, , Finland

Site Status: NOT_YET_RECRUITING

Medical School, University of Thessaly, Larissa University Hospital

Larissa, , Greece

Site Status: RECRUITING

Countries

Finland; Greece

Central Contacts

George Ntaios, MD, PhD

Role: CONTACT

gntaios@med.uth.gr

00302413502888

Facility Contacts

Jukka Putaala, MD PhD

Role: primary

jukkaputaala@hus.fi

George Ntaios, MD, PhD

Role: primary

gntaios@med.uth.gr

00302413502888

Other Identifiers

ERISTA 2016

Identifier Type: -

Identifier Source: org_study_id