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

Last updated: May 15, 2024
Sponsor: Uppsala University
Overall Status: Completed

Phase

N/A

Condition

Atrial Fibrillation

Blood Clots

Chest Pain

Treatment

Early start of NOAC

Late start of NOAC

Clinical Study ID

NCT02961348
U-2015-341
2015-00881
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 888
Treatment Group(s): 2
Primary Treatment: Early start of NOAC
Phase:
Study Start date:
February 15, 2017
Estimated Completion Date:
April 30, 2024

Study 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.

Connect with a study center

  • Alingås Hospital

    Alingsås,
    Sweden

    Site Not Available

  • Enköping Hospital

    Enköping,
    Sweden

    Site Not Available

  • Mälarsjukhuset Hospital

    Eskilstuna,
    Sweden

    Site Not Available

  • Falu Hospital

    Falun,
    Sweden

    Site Not Available

  • Gälivare Hospital

    Gällivare,
    Sweden

    Site Not Available

  • Gävle Hospital

    Gävle,
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital Östra

    Göteborg,
    Sweden

    Site Not Available

  • Hallands Hospital

    Halmstad,
    Sweden

    Site Not Available

  • Helsingborg Hospital

    Helsingborg,
    Sweden

    Site Not Available

  • Karolinska University Hospital - Huddinge

    Huddinge,
    Sweden

    Site Not Available

  • Hudiksvalls sjukhus

    Hudiksvall,
    Sweden

    Site Not Available

  • Hässleholm Hospital

    Hässleholm,
    Sweden

    Site Not Available

  • Ryhov

    Jönköping,
    Sweden

    Site Not Available

  • Kalmar Hopsital

    Kalmar,
    Sweden

    Site Not Available

  • Länssjukhuset Kalmar

    Kalmar,
    Sweden

    Site Not Available

  • Kiruna Hospital

    Kiruna,
    Sweden

    Site Not Available

  • Kristianstad Hospital

    Kristianstad,
    Sweden

    Site Not Available

  • Kungälv Hospital

    Kungälv,
    Sweden

    Site Not Available

  • Köping Hospital

    Köping,
    Sweden

    Site Not Available

  • Lindesberg Hospital

    Lindesberg,
    Sweden

    Site Not Available

  • Lund

    Lund,
    Sweden

    Site Not Available

  • Malmö University Hospital

    Malmö,
    Sweden

    Site Not Available

  • Motala Hospital

    Motala,
    Sweden

    Site Not Available

  • Sahlgrenska Universitetssjukhuset Mölndal

    Mölndal,
    Sweden

    Site Not Available

  • Nyköping Hospital

    Nyköping,
    Sweden

    Site Not Available

  • Oskarshamn Hospital

    Oskarshamn,
    Sweden

    Site Not Available

  • Skaraborg Hospital

    Skövde,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Solna,
    Sweden

    Site Not Available

  • Capio S:t Görans Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Danderyd University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Södersjukhuset

    Stockholm,
    Sweden

    Site Not Available

  • Sundsvall County Hospital

    Sundsvall,
    Sweden

    Site Not Available

  • University Hospital of Umeå

    Umeå,
    Sweden

    Site Not Available

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Site Not Available

  • Hallands Hospital

    Varberg,
    Sweden

    Site Not Available

  • Västerås Hospital

    Västerås,
    Sweden

    Site Not Available

  • Örebro University Hospital

    Örebro,
    Sweden

    Site Not Available

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