Ischemic StrokeNOACISPNCT02353585
Novel Oral Anticoagulants in Stroke Patients
An observational study of Ischemic Stroke and Intracranial Hemorrhages, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intracranial Hemorrhages
- Type of treatment
- Pill or oral medicine
- How many people
- 1,050 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2014to Mar 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to the Stroke Unit at the University Hospital Basel (leading and coordinating center).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Stroke, Intracranial Hemorrhages
- Keywords
- vitamin K-antagonist, novel oral anticoagulants, apixaban, dabigatran, rivaroxaban, edoxaban, direct oral anticoagulants
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional neurological outcome
modified Rankin Scale score at 3 month
Measured: 3 month
Secondary outcomes (2)
Hematoma expansion
hematoma expansion on follow-up imaging for patients with intracerebral hemorrhage
Measured: 0-48 hours
symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage in patients with ischemic stroke
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Stefan Engelter, MD, Principal investigator, Neurology and Stroke CenterPhilippe Lyrer, MD, Principal investigator, Neurology and Stroke Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353585
- Sponsor's protocol ID
- EKNZ: 2014-027
- Acronym
- NOACISP
- Status last verified
- Dec 2022
- First submitted
- 28 Jan 2015
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35396339Schaub 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.
PubMed 34935409Seiffge 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.
PubMed 29394504Seiffge 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.
PubMed 28877563
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02353585
- Acronym / sponsor ID
- NOACISP / EKNZ: 2014-027
- Conditions
- Ischemic Stroke, Intracranial Hemorrhages
- Keywords
- vitamin K-antagonist, novel oral anticoagulants, apixaban, dabigatran, rivaroxaban, edoxaban, direct oral anticoagulants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Heart Foundation
- Study start
- Dec 2014 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to the Stroke Unit at the University Hospital Basel (leading and coordinating center).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional neurological outcome
Time frame: 3 month
modified Rankin Scale score at 3 month
2 secondary outcomes
Hematoma expansion
Time frame: 0-48 hours
symptomatic intracranial hemorrhage
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Results publication: PubMed 35396339Polymeris 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.
- Derived from this study: PubMed 34935409Schaub 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.
- Derived from this study: PubMed 29394504Seiffge 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.
- Derived from this study: PubMed 28877563Seiffge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Engelter, MD principal investigator
Neurology and Stroke Center
Philippe Lyrer, MD principal investigator
Neurology and Stroke Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Intracranial Hemorrhages, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional neurological outcome (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353585, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.