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NCT Number: NCT02961348

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

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).

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Key information

Conditions

Ischemic Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alingås Hospital, Alingsås, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early start of NOAC

Other

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

Late start of NOAC

Other

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

Primary outcomes

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

    Time frame: 90 days

Secondary outcomes

  1. 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

  2. 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

  3. All-cause mortality

    Time frame: 90 days

  4. Functional outcome

    Time frame: 90 days

    Defined by grade on the modified Rankin Scale (mRS)

  5. 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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • The Swedish Stroke Register (Riksstroke)

Registry information

Official study title

Timing of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation: a Prospective Multicenter Registry-based Non-inferiority Randomized Controlled Clinical Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2024
First posted
Nov 10, 2016
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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