TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation
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| ClinicalTrials.gov Identifier: NCT02961348 |
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Recruitment Status :
Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : May 18, 2022
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Sponsor:
Uppsala University
Collaborator:
The Swedish Stroke Register (Riksstroke)
Information provided by (Responsible Party):
Uppsala University
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Stroke Atrial Fibrillation | Other: Early start of NOAC Other: Late start of NOAC | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 888 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Timing of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation: a Prospective Multicenter Registry-based Non-inferiority Randomized Controlled Clinical Trial |
| Actual Study Start Date : | February 15, 2017 |
| Actual Primary Completion Date : | June 10, 2021 |
| Estimated Study Completion Date : | June 30, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Early start of NOAC
Day 1 to day 4 after ischemic stroke onset
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Other: Early start of NOAC
Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation |
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Active Comparator: Late start of NOAC
Day 5 to day 10 after ischemic stroke onset
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Other: Late start of NOAC
Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation |
Primary Outcome Measures :
- Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality [ Time Frame: 90 days ]
Secondary Outcome Measures :
- Recurrent acute ischemic stroke [ Time Frame: 90 days ]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
- Symptomatic intracerebral hemorrhage (S-ICH) [ Time Frame: 90 days ]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
- All-cause mortality [ Time Frame: 90 days ]
- Functional outcome [ Time Frame: 90 days ]Defined by grade on the modified Rankin Scale (mRS)
- Major hemorrhages [ Time Frame: 90 days ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients (≥ 18 years) with acute ischemic stroke and atrial fibrillation
- Eligible and willing to start (or re-start) NOAC
- Registered in The Swedish Stroke Register
- Signed informed consent
Exclusion Criteria:
- Contraindication to NOAC (e.g. ongoing bleeding, mechanical heart valve prosthesis)
- Ongoing therapy with NOAC (without ≥2 days interruption at index stroke)
- International normalized ratio (INR)>1.7
- No second brain imaging (CT/MRI) after thrombolysis/thrombectomy
- Previous randomization in the TIMING study
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): NCT02961348
Locations
Show 36 study locations
Sponsors and Collaborators
Uppsala University
The Swedish Stroke Register (Riksstroke)
Investigators
| Principal Investigator: | Jonas Oldgren, MD. PhD | Dept of Medical Sciences, Uppsala University, Sweden | |
| Principal Investigator: | Signild Åsberg, MD. PhD | Dept of Medical Sciences, Uppsala University, Sweden |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Uppsala University |
| ClinicalTrials.gov Identifier: | NCT02961348 |
| Other Study ID Numbers: |
U-2015-341 2015-00881 ( Other Grant/Funding Number: The Swedish Research Council ) |
| First Posted: | November 10, 2016 Key Record Dates |
| Last Update Posted: | May 18, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Uppsala University:
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Oral anticoagulants (NOAC) |
Additional relevant MeSH terms:
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Stroke Ischemic Stroke Cerebral Infarction Atrial Fibrillation Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |