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

Uppsala University

Status: Completed

Conditions: Atrial Fibrillation; Ischemic Stroke

Treatments: Other: Late start of NOAC; Other: Early start of NOAC

Study type: Interventional

Funder types: Other

Identifiers

NCT02961348

2015-00881 (Other Grant/Funding Number)

U-2015-341

Details and patient eligibility

About

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).

Full 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.

Enrollment: 888 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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888 participants in 2 patient groups

Early start of NOAC

Active Comparator group

Description:

Day 1 to day 4 after ischemic stroke onset

Treatment:

Other: Early start of NOAC

Late start of NOAC

Active Comparator group

Description:

Day 5 to day 10 after ischemic stroke onset

Treatment:

Other: Late start of NOAC