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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 December 2023 |
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Main ID: |
NCT02961348 |
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Date of registration:
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08/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation
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Scientific title:
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Timing of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation: a Prospective Multicenter Registry-based Non-inferiority Randomized Controlled Clinical Trial |
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Date of first enrolment:
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February 15, 2017 |
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Target sample size:
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888 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02961348 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Jonas Oldgren, MD. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept of Medical Sciences, Uppsala University, Sweden |
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Name:
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Signild Åsberg, MD. PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept of Medical Sciences, Uppsala University, Sweden |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Ischemic Stroke
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Intervention(s)
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Other: Early start of NOAC
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Other: Late start of NOAC
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Primary Outcome(s)
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Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality
[Time Frame: 90 days]
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Secondary Outcome(s)
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Functional outcome
[Time Frame: 90 days]
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Symptomatic intracerebral hemorrhage (S-ICH)
[Time Frame: 90 days]
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All-cause mortality
[Time Frame: 90 days]
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Major hemorrhages
[Time Frame: 90 days]
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Recurrent acute ischemic stroke
[Time Frame: 90 days]
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Secondary ID(s)
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2015-00881
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U-2015-341
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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