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

NCT ID: NCT02961348

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

888 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2024-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Ischemic Stroke Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early start of NOAC

Day 1 to day 4 after ischemic stroke onset

Group Type ACTIVE_COMPARATOR

Early start of NOAC

Intervention Type OTHER

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

Late start of NOAC

Day 5 to day 10 after ischemic stroke onset

Group Type ACTIVE_COMPARATOR

Late start of NOAC

Intervention Type OTHER

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

Interventions

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Early start of NOAC

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

Intervention Type OTHER

Late start of NOAC

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

Intervention Type OTHER

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Stroke Register (Riksstroke)

UNKNOWN

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonas Oldgren, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Medical Sciences, Uppsala University, Sweden

Signild Åsberg, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Medical Sciences, Uppsala University, Sweden

Locations

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Alingås Hospital

Alingsås, , Sweden

Site Status

Enköping Hospital

Enköping, , Sweden

Site Status

Mälarsjukhuset Hospital

Eskilstuna, , Sweden

Site Status

Falu Hospital

Falun, , Sweden

Site Status

Gävle Hospital

Gävle, , Sweden

Site Status

Sahlgrenska University Hospital Östra

Gothenburg, , Sweden

Site Status

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Hallands Hospital

Halmstad, , Sweden

Site Status

Hässleholm Hospital

Hässleholm, , Sweden

Site Status

Helsingborg Hospital

Helsingborg, , Sweden

Site Status

Karolinska University Hospital - Huddinge

Huddinge, , Sweden

Site Status

Hudiksvalls sjukhus

Hudiksvall, , Sweden

Site Status

Ryhov

Jönköping, , Sweden

Site Status

Kalmar Hopsital

Kalmar, , Sweden

Site Status

Länssjukhuset Kalmar

Kalmar, , Sweden

Site Status

Kiruna Hospital

Kiruna, , Sweden

Site Status

Köping Hospital

Köping, , Sweden

Site Status

Kungälv Hospital

Kungälv, , Sweden

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Lindesberg Hospital

Lindesberg, , Sweden

Site Status

Lund

Lund, , Sweden

Site Status

Malmö University Hospital

Malmo, , Sweden

Site Status

Motala Hospital

Motala, , Sweden

Site Status

Sahlgrenska Universitetssjukhuset Mölndal

Mölndal, , Sweden

Site Status

Nyköping Hospital

Nyköping, , Sweden

Site Status

Oskarshamn Hospital

Oskarshamn, , Sweden

Site Status

Örebro University Hospital

Örebro, , Sweden

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Skaraborg Hospital

Skövde, , Sweden

Site Status

Karolinska University Hospital

Solna, , Sweden

Site Status

Capio S:t Görans Hospital

Stockholm, , Sweden

Site Status

Danderyd University Hospital

Stockholm, , Sweden

Site Status

Södersjukhuset

Stockholm, , Sweden

Site Status

Sundsvall County Hospital

Sundsvall, , Sweden

Site Status

University Hospital of Umeå

Umeå, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Hallands Hospital

Varberg, , Sweden

Site Status

Västerås Hospital

Västerås, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 29197413 (View on PubMed)

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.

Reference Type RESULT
PMID: 36065821 (View on PubMed)

Other Identifiers

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2015-00881

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U-2015-341

Identifier Type: -

Identifier Source: org_study_id

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