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Completed

NCT Number: NCT03826927

New Oral Anticoagulants (NOAC) in Stroke Patients

Registry to explore characteristics, use and management of new oral anticoagulants (NOAC) and vitamin K antagonists (VKA) treatment among patients with atrial fibrillation (AF) and recent cerebrovascular disease in a "real-world" setting at a stroke centre.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Neurology, Hospital of the University of Basel, Basel, Switzerland

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About this study

Registry to explore characteristics, use and management of new oral anticoagulants (NOAC) and vitamin K antagonists (VKA) treatment among patients with atrial fibrillation (AF) and recent cerebrovascular disease in a "real-world" setting at a stroke centre. Special interest is payed to conditions not or only in part investigated in the large randomised controlled Trials (RCT) and that are specific to patients with cerebrovascular disease. This includes early start of NOAC treatment after recent stroke, very old patients, multimorbidity, patients with a history of intracranial haemorrhage (ICH) and patient satisfaction and preferences with VKA/NOACS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent form (ICF)
  • existing or newly diagnosed AF
  • recent (< 3 month) stroke (ischemic or haemorrhagic) or TIA (=index event)
  • treatment with NOACs or VKAs is continued, changed or initiated for prevention of ischemic events

Exclusion criteria

  • patients not able or unwilling to sign ICF
  • patient is, in the opinion of the investigator, unlikely to comply with the scheduled follow-up visits or is unsuitable for any other reason
  • patients who will not be anticoagulated

Treatment and study plan

treatment with NOACs or VKAs

Other

treatment with NOACs or VKAs initiated or continued for prevention of ischemic events

Primary outcomes

  1. Change in anticoagulation (NOAC and VKA) treatment

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    assessment of details of NOAC or VKA application (start, pause, dosage)

Secondary outcomes

  1. Change in glomerular filtration rate (GFR)

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    impact of kidney function (in particular volatile GFR (ml/min) around the threshold for reduced dosage)

  2. Drug adherence for anticoagulation (VKA) treatment

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    monitor the frequency of VKA use in patients with stroke or TIA attributable to AF, (a) among patients without pre-existing anticoagulation, (b) among patients under insufficient VKA therapy, and (c) among patients with sufficient VKA therapy, assessed by telephone or clinical visit

  3. Change in anticoagulant treatment

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    If anticoagulant treatment was stopped or switched to any other drug (NOAC/VKA), reason for switching will be documented

  4. Recording of Adverse Events (AE)

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    Causality for AE will be assessed as related, possibly related or non-related to the prescribed anticoagulant

  5. Change in modified Rankin Scale (mRS)

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability; scale runs from 0-6, running from perfect health (=0) without symptoms to death (=6)

  6. Co-morbidities

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    Recording of co-morbidities

  7. Drug adherence for anticoagulation (NOAC) treatment

    Time frame: time from index event (= cerebrovascular event) to Follow- up assessments at 3-, 6-, 12- and 24 months after index event

    monitor the frequency of NOAC use in patients with stroke or TIA attributable to AF, assessed by telephone or clinical visit

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

New Oral Anticoagulants in Stroke Patients-Long Term Prevention of Recurrent Stroke in Patients With Atrial Fibrillation- a National Prospective Registry (NOACISP Long Term)

Acronym: NOACISPLongTer

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2019
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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