Not yet recruiting

Study of dabigatran, apixaban and edoxaban for prevention of stroke recurrence in patients with acute ischemic stroke without known atrial fibrillation

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with acute ischemic stroke, a condition where blood flow to part of the brain is blocked. The study aims to test whether blood-thinning medications called Direct Oral Anticoagulants (DOACs) work better than standard treatment in preventing another stroke. The medications being tested include Pradaxa (containing dabigatran), Eliquis (containing apixaban), and Lixiana (containing edoxaban).

The standard treatment in this study consists of blood-thinning medications such as Aspirine (containing acetylsalicylic acid) or Plavix (containing clopidogrel). The study will measure how well these different treatments prevent another stroke from occurring within one year after the first stroke. The study will also look at other important health outcomes such as serious bleeding events.

Participants in this study will be selected based on having high levels of a substance in their blood called MR-proANP, which is measured within three days of their stroke. The treatment period will last for 13 months, during which patients will take their assigned medication daily according to their doctor's instructions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your MR-proANP level (a blood marker) will be measured within 72 hours after stroke symptoms begin
A clinical diagnosis of ischemic stroke (stroke caused by a blood clot) will be confirmed
Step 2
Treatment assignment
You will be randomly assigned to one of two treatment groups:
Group 1: Treatment with DOACs (blood thinning medications) including either Pradaxa, Eliquis, or Lixiana
Group 2: Treatment with standard care using antiplatelet medications (Aspirine 100 mg or Plavix 75 mg)
Step 3
Medication schedule
All medications will be taken by mouth daily
The treatment will continue for 1 year after your stroke
Your assigned medication and dosage will remain constant unless your doctor determines a change is necessary
Step 4
Follow-up period
Your health will be monitored for 1 year after the stroke
Doctors will track any occurrence of new strokes
Other health events will be monitored, including bleeding events and vascular-related issues
Step 5
Study completion
The study will end after 1 year of follow-up
Final evaluation will assess whether any new strokes occurred during the study period
Your participation will help determine which treatment approach is more effective for preventing additional strokes

Who can join the trial?

5 criteria

You must be at least 18 years old
You must have been diagnosed with ischemic stroke (a type of stroke caused by a blood clot blocking blood flow to the brain)
Your blood test must show MR-proANP levels of 200 pmol/L or higher (MR-proANP is a substance in blood that can help predict heart problems) within 72 hours (3 days) from when your stroke symptoms first started
You must be able to understand and sign an informed consent form that explains the study details according to your country's requirements
Both men and women can participate in this study

Who cannot join the trial?

15 criteria

Age below 18 years
Active major bleeding (significant blood loss currently occurring)
Previous allergic reactions to anticoagulant medications (blood thinners)
Severe kidney failure requiring dialysis
Current use of blood thinning medications other than those specified in the study
Pregnancy or breastfeeding
History of hemorrhagic stroke (bleeding in the brain)
Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >100 mmHg)
Life expectancy less than 6 months due to other medical conditions
Participation in other clinical trials within the past 30 days
Presence of artificial heart valves
Severe liver disease affecting blood clotting
Recent major surgery within the past month
Active cancer requiring treatment
Unable to take oral medications

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Virgen del Rocío University Hospital
Verified
Sevilla, Spain

Trial locations

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Investigated drugs

Direct Oral Anticoagulants (DOACs)
These are blood-thinning medications that help prevent blood clots. They work by directly blocking specific proteins involved in blood clotting. These medications are used to reduce the risk of stroke in patients who have had a previous stroke.
Antiplatelets
These medications help prevent blood clots by stopping blood platelets from sticking together. They are commonly used as a standard treatment to prevent recurring strokes. They work differently from blood thinners and are often prescribed to patients who have experienced a stroke.
MR-proANP
This is not a medication but a biological marker (peptide) that is measured in the blood to help identify patients who might be at higher risk of stroke. It's used in this study to select which patients should receive which treatment.

What is already known about the treatment

MR-proANP
A naturally occurring peptide hormone (midregional proatrial natriuretic peptide) that serves as a biomarker for cardiovascular conditions, particularly in stroke assessment and management. This substance is measured in blood tests to help guide treatment decisions in patients with acute ischemic stroke, especially in determining the risk of atrial fibrillation and subsequent stroke recurrence. The biomarker aids clinicians in deciding between anticoagulation therapy with DOACs or standard antiplatelet treatment, representing a personalized medicine approach in secondary stroke prevention.
DOACs
Direct Oral Anticoagulants are modern blood-thinning medications taken by mouth that work by directly inhibiting specific clotting factors in the blood. These medications are used for preventing stroke recurrence in patients who have experienced an acute ischemic stroke, particularly when there's an elevated risk of atrial fibrillation. DOACs represent an alternative to traditional antiplatelet therapy in stroke prevention, offering potentially superior protection against future stroke events with a more predictable anticoagulant effect compared to older medications.

Investigated diseases

Acute Ischemic Stroke - A condition that occurs when blood flow to a part of the brain is suddenly blocked by a clot, preventing oxygen and nutrients from reaching brain tissue. During an acute ischemic stroke, brain cells in the affected area begin to die within minutes due to lack of blood supply. The symptoms typically develop suddenly and may include weakness or numbness on one side of the body, difficulty speaking, vision problems, and trouble with balance or coordination. This type of stroke accounts for the majority of all stroke cases and can affect people of any age, though the risk increases with age. The severity of symptoms depends on which area of the brain is affected and how long the blood flow was disrupted.