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Novel Oral Anticoagulants in Stroke Patients (NOACISP)

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ClinicalTrials.gov Identifier: NCT02353585
Recruitment Status : Recruiting
First Posted : February 2, 2015
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Swiss Heart Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The present study will monitor and explore acute neurovascular emergencies in patients treated with NOACs compared to those under treatment with VKAs. The primary aims of this study are: (1) To investigate characteristics, management and outcome of intracranial hemorrhage (ICH) in patients treated with NOAC compared to VKA. (2) To investigate the management and outcome of patients with acute ischaemic stroke under NOAC compared to VKA.

Condition or disease
Ischemic Stroke Intracranial Hemorrhages

Detailed Description:

Background: For decades, oral anticoagulation with vitamin K antagonists (VKA) has been the sole option for the treatment of a variety of diseases like venous thrombosis, pulmonary embolism and the prevention of stroke in patients with atrial fibrillation. Despite its clinical efficacy, the treatment with VKA is associated with multiple well-known limitations, including a significant risk of major hemorrhages (especially intracerebral hemorrhage), food and drug interactions, and the need for continued coagulation monitoring for dose control. Recent randomised controlled trials (RCT) have provided promising results with novel oral anticoagulants (NOAC) that do not exhibit the limitations of VKA. Especially for stroke prevention in patients with atrial fibrillation, NOAC have shown comparable or even better protective efficacy while causing less intracerebral hemorrhages (ICH). Eventually, this has led to the marketing approval of Apixaban, Rivaroxaban and Dabigatran for stroke prevention in patients with atrial fibrillation by the Swiss Health Authority (Swissmedic).

Even though the trials reported on the occurrence of acute ischemic strokes or intracerebral hemorrhages in patients under the treatment with NOAC, only limited data and few case reports have been published so far. Thus, aspects concerning the treatment decisions and concepts of management of acute ischemic stroke under NOAC were not addressed in these trials; in particular, the use of acute revascularisation therapies like intravenous thrombolysis (IVT) or intra-arterial treatment (IAT) remains unanswered. Furthermore, characteristics, management and outcome of ICH under the treatment with NOAC were not addressed. Thus, information on relevant aspects of the management of acute neurovascular emergencies under NOACs remains scarce.

Aims: The present study will monitor and explore acute neurovascular emergencies in patients treated with NOACs compared to those under treatment with VKAs. The primary aims of this study are: (1) To investigate characteristics, management and outcome of intracranial hemorrhage (ICH) in patients treated with NOAC compared to VKA. (2) To investigate the management and outcome of patients with acute ischaemic stroke under NOAC compared to VKA.

Methodology: We launch an observational, multi-center (Switzerland and Europe) registry. The leading and coordinating center is located at the Stroke Center of the University Hospital Basel. The following groups of patients admitted to a Stroke Unit of one of the participating centers will be enrolled: A) Patients with ICH occurring while under the treatment with NOAC (last intake <48 hours) or VKA and B) Patients with acute ischaemic stroke occurring while under treatment with NOAC (last intake <48 hours) or VKA.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: A Registry of Novel Oral AntiCoagulants and Vitamin K-antagonists In Stroke Patients - a Multi-center Audit Addressing a) Intracerebral Haemorrhage and b) Acute Ischemic Stroke in Patients Treated With Oral Anticoagulants
Study Start Date : December 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Intracranial hemorrhage
Intracranial hemorrhage occuring in patients on novel oral anticoagulants (NOAC) or vitamin-K antagonists
Acute ischemic stroke
Acute ischemic stroke occuring in patients on novel oral anticoagulants (NOAC) or vitamin K antagonists (VKA)



Primary Outcome Measures :
  1. Functional neurological outcome [ Time Frame: 3 month ]
    modified Rankin Scale score at 3 month


Secondary Outcome Measures :
  1. Hematoma expansion [ Time Frame: 0-48 hours ]
    hematoma expansion on follow-up imaging for patients with intracerebral hemorrhage

  2. symptomatic intracranial hemorrhage [ Time Frame: 7 days ]
    symptomatic intracranial hemorrhage in patients with ischemic stroke



Information from the National Library of Medicine

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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
patients admitted to the Stroke Unit at the University Hospital Basel (leading and coordinating center).
Criteria

Inclusion Criteria:

  • Patients with ICH occurring while under treatment with NOACs (last intake <48 hours) or VKAs for any indication;
  • Patients with acute ischaemic stroke occurring while under treatment with NOACs (last intake <48 hours) or VKAs for any indication.

Exclusion Criteria:

  • The patient is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
  • Patients <18 years of age

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): NCT02353585


Contacts
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Contact: David Seiffge, MD 0041-61-32 87278 david.seiffge@usb.ch
Contact: Stefan Engelter, MD 0041-61-2654184 stefan.engelter@usb.ch

Locations
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Switzerland
Stroke Center Recruiting
Basel, Switzerland, 4031
Contact: David Seiffge, MD    0041-61-3287278    david.seiffge@usb.ch   
Principal Investigator: David Seiffge, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss Heart Foundation
Investigators
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Principal Investigator: Stefan Engelter, MD Neurology and Stroke Center
Principal Investigator: Philippe Lyrer, MD Neurology and Stroke Center

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02353585    
Other Study ID Numbers: EKNZ: 2014-027
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Keywords provided by University Hospital, Basel, Switzerland:
vitamin K-antagonist
novel oral anticoagulants
apixaban
dabigatran
rivaroxaban
edoxaban
direct oral anticoagulants
Additional relevant MeSH terms:
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Stroke
Intracranial Hemorrhages
Ischemia
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Vitamins
Vitamin K
Anticoagulants
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants