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

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What is this study about?

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.

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

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)

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitario Virgen Macarena	Sevilla	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hkrnezql Dg Lf Scknv Cyij I Sdwj Pdg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Greece	Not yet recruiting	01.06.2021
Spain	Not yet recruiting	01.06.2021

Trial locations

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.

Investigated diseases:

Ischaemic stroke

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.

Trial ID:

2024-517600-11-01

Protocol code:

MOSES

NCT ID:

NCT03961334

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?