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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-00881 | Other Grant/Funding Number | The Swedish Research Council |
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| Name | Class |
|---|---|
| The Swedish Stroke Register (Riksstroke) | UNKNOWN |
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This study will compare early with late start of treatment with Non-vitamin K oral anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation; it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset) while the other half will start late (5-10 days after stroke onset).
Oral anticoagulation therapy is well established and highly recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation, but the optimal time point to start after an acute ischemic stroke is not known.
The intervention in this study will be timing of treatment onset. The choice of NOAC (i.e. apixaban, dabigatran, edoxaban or rivaroxaban) after the acute ischemic stroke is at the discretion of the treating physician.
This study will use the Swedish Stroke Register for enrolment, randomization and follow-up, with additional data linkage from other mandatory national registers. Primary outcome will be assessed at 90 days and secondary outcomes (including all-cause mortality and health economic analyses) and will be assessed at 90 days and up to one year after the index ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early start of NOAC | Active Comparator | Day 1 to day 4 after ischemic stroke onset |
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| Late start of NOAC | Active Comparator | Day 5 to day 10 after ischemic stroke onset |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early start of NOAC | Other | Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent acute ischemic stroke | Defined as a new focal neurological deficit of sudden onset lasting at least 24 h (or <24 h if following therapeutic intervention, i.e. thrombolysis or thrombectomy, or if the deficit results in death < 24 h), occurring >24 hours after the index ischemic stroke, irrespective of vascular territory and that is not attributable to edema, brain shift, hemorrhagic transformation, intercurrent illness, hypoxia, or drug toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonas Oldgren, MD. PhD | Dept of Medical Sciences, Uppsala University, Sweden | Principal Investigator |
| Signild Åsberg, MD. PhD | Dept of Medical Sciences, Uppsala University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alingås Hospital | Alingsås | Sweden | ||||
| Enköping Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29197413 | Background | Asberg S, Hijazi Z, Norrving B, Terent A, Ohagen P, Oldgren J. Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial. Trials. 2017 Dec 2;18(1):581. doi: 10.1186/s13063-017-2313-9. | |
| 36065821 | Result | Oldgren J, Asberg S, Hijazi Z, Wester P, Bertilsson M, Norrving B; National TIMING Collaborators. Early Versus Delayed Non-Vitamin K Antagonist Oral Anticoagulant Therapy After Acute Ischemic Stroke in Atrial Fibrillation (TIMING): A Registry-Based Randomized Controlled Noninferiority Study. Circulation. 2022 Oct 4;146(14):1056-1066. doi: 10.1161/CIRCULATIONAHA.122.060666. Epub 2022 Sep 6. |
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| Late start of NOAC | Other | Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation |
|
| 90 days |
| Symptomatic intracerebral hemorrhage (S-ICH) | Defined as a new focal neurological deficit of sudden onset lasting at least 24 h with documented intracerebral hemorrhage (ICH) on imaging (computed tomography (CT) or magnetic resonance imaging (MRI)). Any intraparenchymal hematoma (≥10mm) will be considered, including hemorrhagic transformation of the index ischemic stroke. However microhemorrhages (<10mm) are not considered to be an ICH. ICH will be classified as symptomatic if it is associated with ≥4 points in total NIHSS or ≥2 points in one NIHSS category | 90 days |
| All-cause mortality | 90 days |
| Functional outcome | Defined by grade on the modified Rankin Scale (mRS) | 90 days |
| Major hemorrhages | Defined as bleedings that are fatal or life-threatening (according to the definition by the International Society on Thrombosis and Haemostasis) or lead to hospitalization | 90 days |
| Enköping |
| Sweden |
| Mälarsjukhuset Hospital | Eskilstuna | Sweden |
| Falu Hospital | Falun | Sweden |
| Gävle Hospital | Gävle | Sweden |
| Sahlgrenska University Hospital Östra | Gothenburg | Sweden |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Hallands Hospital | Halmstad | Sweden |
| Hässleholm Hospital | Hässleholm | Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Karolinska University Hospital - Huddinge | Huddinge | Sweden |
| Hudiksvalls sjukhus | Hudiksvall | Sweden |
| Ryhov | Jönköping | Sweden |
| Kalmar Hopsital | Kalmar | Sweden |
| Länssjukhuset Kalmar | Kalmar | Sweden |
| Kiruna Hospital | Kiruna | Sweden |
| Köping Hospital | Köping | Sweden |
| Kungälv Hospital | Kungälv | Sweden |
| Lindesberg Hospital | Lindesberg | Sweden |
| Lund | Lund | Sweden |
| Malmö University Hospital | Malmö | Sweden |
| Motala Hospital | Motala | Sweden |
| Sahlgrenska Universitetssjukhuset Mölndal | Mölndal | Sweden |
| Nyköping Hospital | Nyköping | Sweden |
| Oskarshamn Hospital | Oskarshamn | Sweden |
| Örebro University Hospital | Örebro | Sweden |
| Skaraborg Hospital | Skövde | Sweden |
| Karolinska University Hospital | Solna | Sweden |
| Capio S:t Görans Hospital | Stockholm | Sweden |
| Danderyd University Hospital | Stockholm | Sweden |
| Södersjukhuset | Stockholm | Sweden |
| Sundsvall County Hospital | Sundsvall | Sweden |
| University Hospital of Umeå | Umeå | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Hallands Hospital | Varberg | Sweden |
| Västerås Hospital | Västerås | Sweden |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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