TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation
Timing of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation: a Prospective Multicenter Registry-based Non-inferiority Randomized Controlled Clinical Trial
2 other identifiers
interventional
888
1 country
36
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2016
CompletedFirst Posted
Study publicly available on registry
November 10, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedMay 16, 2024
May 1, 2024
4.3 years
November 8, 2016
May 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality
90 days
Secondary Outcomes (5)
Recurrent acute ischemic stroke
90 days
Symptomatic intracerebral hemorrhage (S-ICH)
90 days
All-cause mortality
90 days
Functional outcome
90 days
Major hemorrhages
90 days
Study Arms (2)
Early start of NOAC
ACTIVE COMPARATORDay 1 to day 4 after ischemic stroke onset
Late start of NOAC
ACTIVE COMPARATORDay 5 to day 10 after ischemic stroke onset
Interventions
Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation
Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- The Swedish Stroke Register (Riksstroke)collaborator
Study Sites (36)
Alingås Hospital
Alingsås, Sweden
Enköping Hospital
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
Malmo, 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
Related Publications (2)
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.
PMID: 29197413BACKGROUNDOldgren 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.
PMID: 36065821RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2016
First Posted
November 10, 2016
Study Start
February 15, 2017
Primary Completion
June 10, 2021
Study Completion
April 30, 2024
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share