ClinicalTrials.gov
ClinicalTrials.gov Menu

Αdherence and Persistence to Oral Anticoagulation in ΑF Patients With Previous Ischemic Stroke (ADHERE-OAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03463421
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Helsinki University
Information provided by (Responsible Party):
George Ntaios, University of Thessaly

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

Condition or disease
Ischemic Stroke

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Years
Official Title: A Prospective Assessment of Adherence and Persistence to Oral Anticoagulation in Ischemic Stroke Patients With Atrial Fibrillation: Incidence, Predictors and the Prognostic Role of the SAMe-TT2R2 Score.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Modified Morisky Medication Adherence Scale [ Time Frame: Up to 5 years ]
    Self-reported patient adherence to oral anticoagulation (Range 0-3) Values 0-1: low motivation, low knowledge Values 2-3: high motivation, high knowledge


Secondary Outcome Measures :
  1. Proportion of patients still on the initial anticoagulant at the time of follow-up assessment [ Time Frame: Up to 5 years ]
    Persistence to oral anticoagulation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463421


Contacts
Contact: George Ntaios, MD, PhD 00302413502888 gntaios@med.uth.gr

Locations
Finland
Department of Neurology, Helsinki University Hospital, Helsinki, FinlandHelsinki University Hospital Not yet recruiting
Helsinki, Finland
Contact: Jukka Putaala, MD PhD       jukkaputaala@hus.fi   
Principal Investigator: Jukka Putaala, MD PhD         
Greece
Medical School, University of Thessaly, Larissa University Hospital Recruiting
Larissa, Greece, 41110
Contact: George Ntaios, MD, PhD    00302413502888    gntaios@med.uth.gr   
Principal Investigator: George Ntaios, MD, PhD         
Sponsors and Collaborators
University of Thessaly
Helsinki University
Investigators
Principal Investigator: George Ntaios, MD, PhD Medical School, University of Thessaly, Larissa University Hospital

Responsible Party: George Ntaios, MD, MSc (ESO Stroke Medicine), PhD, FESO, Assistant Professor of Internal Medicine, Medical School, University of Thessaly, Larissa University Hospital, University of Thessaly
ClinicalTrials.gov Identifier: NCT03463421     History of Changes
Other Study ID Numbers: ERISTA 2016
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by George Ntaios, University of Thessaly:
Adherence to oral anticoagulation
Persistence to oral anticoagulation
AF patients
Previous ischemic stroke

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia