About the study

The STROACT study evaluates the efficacy and safety of thrombolytic treatment in patients with acute ischemic stroke who are receiving oral anticoagulants.

The project is a multicentre, randomised phase II clinical trial conducted in a double-blind, placebo-controlled design.

What is ischemic stroke?

Stroke is one of the leading causes of death and long-term disability in adults. Approximately 85% of all strokes are ischemic strokes, caused by blockage or severe narrowing of an artery supplying blood to the brain.

One of the most common causes of ischemic stroke is cardioembolic disease, most frequently associated with atrial fibrillation.

The clinical challenge

Patients with atrial fibrillation are often treated with oral anticoagulants (NOACs), which significantly reduce the risk of stroke. Nevertheless, ischemic stroke may still occur in some patients.

In such situations, most patients are not eligible for reperfusion therapy because the combination of anticoagulation and thrombolytic treatment carries a high risk of bleeding complications.

Why is a new approach needed?

It is estimated that approximately 8,000 ischemic strokes occur annually in Poland among patients receiving oral anticoagulants.

Most of these patients currently have limited access to effective reperfusion treatment, which significantly worsens their prognosis.

What treatment strategy is being evaluated?

The study evaluates a treatment pathway consisting of:

• administration of a specific antidote reversing the anticoagulant effect;
• subsequent thrombolytic treatment with recombinant tissue plasminogen activator (rtPA).

This strategy may enable the safe use of reperfusion therapy in patients who would otherwise not qualify for this treatment.

Study design

STROACT is conducted as a multicentre, randomised phase II clinical trial using a double-blind, placebo-controlled design.

Participants are assigned to parallel study groups, and both efficacy and safety are evaluated under controlled clinical conditions.

Study population

Approximately 300 patients with acute ischemic stroke receiving oral anticoagulants are planned for enrolment.

Study objectives

The objective of the study is to develop an effective and safe reperfusion treatment strategy for patients with acute ischemic stroke who are receiving oral anticoagulants.

The study results may contribute to changes in treatment standards for this patient population and improve clinical outcomes.

Participating centres and experience

The project is conducted as a multicentre study involving specialised neurology centres. The coordinating institution is the Medical University of Gdańsk in collaboration with the University Clinical Centre in Gdańsk.

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA).

Project number: 2019/ABM/01/00084.

Project duration: 01 July 2020 – 30 June 2026.

Total project value: PLN 20,795,000.00.