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
|Condition or disease|
|Ischemic Stroke Intracranial Hemorrhages|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|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|
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)
- Functional neurological outcome [ Time Frame: 3 month ]modified Rankin Scale score at 3 month
- Hematoma expansion [ Time Frame: 0-48 hours ]hematoma expansion on follow-up imaging for patients with intracerebral hemorrhage
- symptomatic intracranial hemorrhage [ Time Frame: 7 days ]symptomatic intracranial hemorrhage in patients with ischemic stroke
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
|Contact: David Seiffge, MD||0041-61-32 firstname.lastname@example.org|
|Contact: Stefan Engelter, MDemail@example.com|
|Basel, Switzerland, 4031|
|Contact: David Seiffge, MD 0041-61-3287278 firstname.lastname@example.org|
|Principal Investigator: David Seiffge, MD|
|Principal Investigator:||Stefan Engelter, MD||Neurology and Stroke Center|
|Principal Investigator:||Philippe Lyrer, MD||Neurology and Stroke Center|