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

November 28, 2023 updated by: Uppsala University

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

888

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Alingsås, Sweden
        • Alingås Hospital
      • Enköping, Sweden
        • Enköping Hospital
      • Eskilstuna, Sweden
        • Mälarsjukhuset Hospital
      • Falun, Sweden
        • Falu Hospital
      • Gävle, Sweden
        • Gävle Hospital
      • Göteborg, Sweden
        • Sahlgrenska University Hospital
      • Göteborg, Sweden
        • Sahlgrenska University Hospital Östra
      • Halmstad, Sweden
        • Hallands hospital
      • Helsingborg, Sweden
        • Helsingborg Hospital
      • Huddinge, Sweden
        • Karolinska University Hospital - Huddinge
      • Hudiksvall, Sweden
        • Hudiksvalls sjukhus
      • Hässleholm, Sweden
        • Hässleholm Hospital
      • Jönköping, Sweden
        • Ryhov
      • Kalmar, Sweden
        • Kalmar Hopsital
      • Kalmar, Sweden
        • Länssjukhuset Kalmar
      • Kiruna, Sweden
        • Kiruna Hospital
      • Kungälv, Sweden
        • Kungälv Hospital
      • Köping, Sweden
        • Köping Hospital
      • Lindesberg, Sweden
        • Lindesberg Hospital
      • Lund, Sweden
        • Lund
      • Malmö, Sweden
        • Malmö University Hospital
      • Motala, Sweden
        • Motala Hospital
      • Mölndal, Sweden
        • Sahlgrenska Universitetssjukhuset Mölndal
      • Nyköping, Sweden
        • Nyköping Hospital
      • Oskarshamn, Sweden
        • Oskarshamn Hospital
      • Skövde, Sweden
        • Skaraborg Hospital
      • Solna, Sweden
        • Karolinska University Hospital
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden
        • Capio S:t Görans Hospital
      • Stockholm, Sweden
        • Danderyd University Hospital
      • Sundsvall, Sweden
        • Sundsvall County Hospital
      • Umeå, Sweden
        • University Hospital of Umeå
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Varberg, Sweden
        • Hallands hospital
      • Västerås, Sweden
        • Västerås hospital
      • Örebro, Sweden
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early start of NOAC
Day 1 to day 4 after ischemic stroke onset
Other: Early start of NOAC
Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation
Active Comparator: Late start of NOAC
Day 5 to day 10 after ischemic stroke onset
Other: Late start of NOAC
Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 90 days
90 days
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
90 days
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
90 days
Functional outcome
Time Frame: 90 days
Defined by grade on the modified Rankin Scale (mRS)
90 days
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

June 10, 2021

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimated)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-2015-341
  • 2015-00881 (Other Grant/Funding Number: The Swedish Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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