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

NCT03463421 | Unknown DMC

• 1 other identifier: ERISTA 2016
• Study Type: observational
• Target: 1,200
• Locations: 2 countries
• Sites: 2

Brief Summary

The aims of this project are to:

1. 1.investigate the adherence and persistence to anticoagulation (and in specific, to VKAs and NOACs) in AF patients with previous ischemic stroke;
2. 2.identify predictors of poor adherence and persistence and
3. 3.assess whether the SAMe-TT2R2 score predicts adherence and persistence to anticoagulation

Conditions

Ischemic Stroke

Keywords

Adherence to oral anticoagulation; Persistence to oral anticoagulation; AF patients; Previous ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Adherence to medication

  The Adherence to Refills and Medications Scale (ARMS) will be used to assess adherence to medication. The ARMS consists of 12 items, each one representing a 4-point question. It was also designed to include two distinct subscales, and this was supported in the overall factor analysis. The 8-item medication taking subscale assesses a patient's ability to correctly self-administer the prescribed regimen. The 4-item prescription refill subscale assesses a patient's ability to refill medications on schedule. Conceptually, these represent different types of problems in medication use In the publication that introduced the ARMS score (Kripalani et al. Value Health. 2009 Jan-Feb;12(1):118-23), on the eight-item taking medications subscale, scores ranged from 8 to 29 (mean = 10.33, SD = 2.66), and in the four-item refilling medications subscale, scores from 4 to 14 were reported (mean = 5.99, SD = 1.98). Lower scores indicate better adherence.

  Up to 5 years

Secondary Outcomes (1)

• Proportion of patients still on the initial anticoagulant at the time of follow-up assessment

  Up to 5 years

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

The dataset will be derived mainly from two high quality, prospective stroke registries: the Larissa Stroke Outcome Registry (LASTRO)(Larissa University Hospital, Greece) and the Helsinki Stroke Registry (Helsinki University Hospital, Finland)

You may qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead
• University of Helsinki: collaborator

Study Sites (2)

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

Helsinki, Finland

NOT YET RECRUITING

Medical School, University of Thessaly, Larissa University Hospital

Larissa, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• George Ntaios, MD, PhD

  Medical School, University of Thessaly, Larissa University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Ntaios, MD, PhD

CONTACT

00302413502888; gntaios@med.uth.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc (ESO Stroke Medicine), PhD, FESO, Assistant Professor of Internal Medicine, Medical School, University of Thessaly, Larissa University Hospital

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 13, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: February 1, 2020
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

FI (1); GR (1)