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

Recruiting

Phase N/A Results N/A

Trial Description

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

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

Interventions

  • Early start of NOAC Other
    Intervention Desc: Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation
    ARM 1: Kind: Experimental
    Label: Early start of NOAC
    Description: Day 1 to day 4 after ischemic stroke onset
  • Late start of NOAC Other
    Intervention Desc: Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation
    ARM 1: Kind: Experimental
    Label: Late start of NOAC
    Description: Day 5 to day 10 after ischemic stroke onset

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite outcome of recurrent ischemic stroke, symptomatic intracerebral hemorrhage, or all-cause mortality 90 days
Secondary Recurrent acute ischemic stroke 90 days
Secondary Symptomatic intracerebral hemorrhage (S-ICH) 90 days
Secondary All-cause mortality 90 days
Secondary Functional outcome 90 days
Secondary Major hemorrhages 90 days

Sponsors