Novel Oral Anticoagulants in Stroke Patients

NCT02353585 | Completed

• 1 other identifier: EKNZ: 2014-027
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Intracranial Hemorrhages

Keywords

vitamin K-antagonist; novel oral anticoagulants; apixaban; dabigatran; rivaroxaban; edoxaban; direct oral anticoagulants

Outcome Measures

Primary Outcomes (1)

• Functional neurological outcome

  modified Rankin Scale score at 3 month

  3 month

Secondary Outcomes (2)

• Hematoma expansion

  0-48 hours

• symptomatic intracranial hemorrhage

  7 days

Study Arms (2)

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)

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

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Heart Foundation: collaborator

Study Sites (1)

Stroke Center

Basel, 4031, Switzerland

Location

Related Publications (4)

• Polymeris AA, Meinel TR, Oehler H, Holscher K, Zietz A, Scheitz JF, Nolte CH, Stretz C, Yaghi S, Stoll S, Wang R, Hausler KG, Hellwig S, Klammer MG, Litmeier S, Leon Guerrero CR, Moeini-Naghani I, Michel P, Strambo D, Salerno A, Bianco G, Cereda C, Uphaus T, Groschel K, Katan M, Wegener S, Peters N, Engelter ST, Lyrer PA, Bonati LH, Grunder L, Ringleb PA, Fischer U, Kallmunzer B, Purrucker JC, Seiffge DJ. Aetiology, secondary prevention strategies and outcomes of ischaemic stroke despite oral anticoagulant therapy in patients with atrial fibrillation. J Neurol Neurosurg Psychiatry. 2022 Jun;93(6):588-598. doi: 10.1136/jnnp-2021-328391. Epub 2022 Apr 8.

  PMID: 35396339 RESULT

• Schaub F, Polymeris AA, Schaedelin S, Hert L, Meya L, Thilemann S, Traenka C, Wagner B, Seiffge D, Gensicke H, De Marchis GM, Bonati L, Engelter ST, Peters N, Lyrer P. Differences Between Anticoagulated Patients With Ischemic Stroke Versus Intracerebral Hemorrhage. J Am Heart Assoc. 2022 Jan 4;11(1):e023345. doi: 10.1161/JAHA.121.023345. Epub 2021 Dec 22.

  PMID: 34935409 DERIVED

• Seiffge DJ, Kagi G, Michel P, Fischer U, Bejot Y, Wegener S, Zedde M, Turc G, Cordonnier C, Sandor PS, Rodier G, Zini A, Cappellari M, Schadelin S, Polymeris AA, Werring D, Thilemann S, Maestrini I, Berge E, Traenka C, Vehoff J, De Marchis GM, Kapauer M, Peters N, Sirimarco G, Bonati LH, Arnold M, Lyrer PA, De Maistre E, Luft A, Tsakiris DA, Engelter ST; Novel Oral Anticoagulants in Stroke Patients study group. Rivaroxaban plasma levels in acute ischemic stroke and intracerebral hemorrhage. Ann Neurol. 2018 Mar;83(3):451-459. doi: 10.1002/ana.25165. Epub 2018 Mar 3.

  PMID: 29394504 DERIVED

• Seiffge DJ, Traenka C, Polymeris AA, Thilemann S, Wagner B, Hert L, Muller MD, Gensicke H, Peters N, Nickel CH, Stippich C, Sutter R, Marsch S, Fisch U, Guzman R, De Marchis GM, Lyrer PA, Bonati LH, Tsakiris DA, Engelter ST. Intravenous Thrombolysis in Patients with Stroke Taking Rivaroxaban Using Drug Specific Plasma Levels: Experience with a Standard Operation Procedure in Clinical Practice. J Stroke. 2017 Sep;19(3):347-355. doi: 10.5853/jos.2017.00395. Epub 2017 Sep 6.

  PMID: 28877563 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Engelter, MD

  Neurology and Stroke Center

  PRINCIPAL INVESTIGATOR

• Philippe Lyrer, MD

  Neurology and Stroke Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

CH (1)