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AzTrials

Ischemic StrokeNCT02961348

TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation

A study testing Early start of NOAC and Late start of NOAC in people with Ischemic Stroke and Atrial Fibrillation, run by Uppsala University at 36 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Atrial Fibrillation
What is being tested?
Early start of NOAC and Late start of NOAC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
888 participants
Where
36 sitesSweden
Study dates
15 Feb 2017to 30 Apr 2024
Phase
Interventional
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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

Sweden36 sites

  • Alingås Hospital

    Alingsås

  • Enköping Hospital

    Enköping

  • Mälarsjukhuset Hospital

    Eskilstuna

  • Falu Hospital

    Falun

  • Gävle Hospital

    Gävle

  • Sahlgrenska University Hospital Östra

    Gothenburg

  • Sahlgrenska University Hospital

    Gothenburg

  • Hallands Hospital

    Halmstad

  • Hässleholm Hospital

    Hässleholm

  • Helsingborg Hospital

    Helsingborg

  • Karolinska University Hospital - Huddinge

    Huddinge

  • Hudiksvalls sjukhus

    Hudiksvall

  • Ryhov

    Jönköping

  • Kalmar Hopsital

    Kalmar

  • Länssjukhuset Kalmar

    Kalmar

  • Kiruna Hospital

    Kiruna

  • Köping Hospital

    Köping

  • Kungälv Hospital

    Kungälv

  • Lindesberg Hospital

    Lindesberg

  • Lund

    Lund

  • Malmö University Hospital

    Malmö

  • Sahlgrenska Universitetssjukhuset Mölndal

    Mölndal

  • Motala Hospital

    Motala

  • Nyköping Hospital

    Nyköping

  • Örebro University Hospital

    Örebro

  • Oskarshamn Hospital

    Oskarshamn

  • Skaraborg Hospital

    Skövde

  • Karolinska University Hospital

    Solna

  • Capio S:t Görans Hospital

    Stockholm

  • Danderyd University Hospital

    Stockholm

  • Södersjukhuset

    Stockholm

  • Sundsvall County Hospital

    Sundsvall

  • University Hospital of Umeå

    Umeå

  • Uppsala University Hospital

    Uppsala

  • Hallands Hospital

    Varberg

  • Västerås Hospital

    Västerås

Other trials in Sweden

About this study

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

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).

Read the detailed description

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.

Being tested
Early start of NOAC, Late start of NOAC
Keywords
Oral anticoagulants (NOAC)
Medical subject headings
Ischemic Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early start of NOACOther

    Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation

  • Late start of NOACOther

    Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation

Study groups in NCT02961348
Study groupRoleWhat they receive
Early start of NOACActive comparatorDay 1 to day 4 after ischemic stroke onset
Receives: Other: Early start of NOAC
Late start of NOACActive comparatorDay 5 to day 10 after ischemic stroke onset
Receives: Other: Late start of NOAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality

    Measured: 90 days

Secondary outcomes (5)

  1. 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

    Measured: 90 days

  2. 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

    Measured: 90 days

  3. All-cause mortality

    Measured: 90 days

  4. Functional outcome

    Defined by grade on the modified Rankin Scale (mRS)

    Measured: 90 days

  5. 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

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion10 Jun 2021
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
888 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02961348
Sponsor's protocol ID
U-2015-341
Other IDs
2015-00881, 2015
Status last verified
May 2024
First submitted
8 Nov 2016
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29197413

  • 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.

    PubMed 36065821

Questions about this trial

What is this clinical trial studying?

A study testing Early start of NOAC and Late start of NOAC in people with Ischemic Stroke and Atrial Fibrillation, run by Uppsala University at 36 sites in Sweden.

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 4 inclusion and 5 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Sweden. 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?

Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality (time frame: 90 days). 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 NCT02961348, which also lists 2 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 16 May 2024.

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