Study on the Use of Alteplase and Andexanet Alfa for Patients with Acute Ischemic Stroke on Non-Vitamin K Oral Anticoagulants

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What is this study about?

This clinical trial is focused on studying the treatment of acute ischemic stroke, a condition where blood flow to a part of the brain is blocked, leading to potential brain damage. The study involves the use of a medication called alteplase, which is a type of drug known as a thrombolytic or “clot-buster.” This medication is given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The trial also involves a specific antidote to reverse the effects of certain blood thinners, known as non-vitamin K antagonist oral anticoagulants, which some patients may be taking. Another medication used in the study is andexanet alfa, which acts as a reversal agent for these blood thinners.

The purpose of the study is to evaluate the effectiveness and safety of using alteplase in patients who have had an acute ischemic stroke and are on these blood thinners. The study is designed to compare the outcomes of patients receiving the treatment with those receiving a placebo. Participants will be randomly assigned to different groups, and neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This is known as a double-blind study. The trial will monitor patients over a period to assess their recovery and any changes in their condition.

Throughout the study, participants will receive regular assessments to track their progress. These assessments will help determine how well the treatment is working and if there are any side effects. The study aims to provide valuable information on whether the use of alteplase is a safe and effective option for patients with acute ischemic stroke who are on specific blood thinners. The findings from this study could potentially lead to improved treatment options for stroke patients in the future.

1 joining the study

Upon joining the study, you will provide your consent to participate. If you are unable to sign due to a severe neurological condition, oral consent is acceptable, provided it is certified by two independent witnesses or a legal representative.

2 initial assessment

You will undergo an initial assessment to confirm the diagnosis of acute ischemic stroke. This includes checking your medical history and current medications, specifically if you are on a non-vitamin K antagonist oral anticoagulant like apixaban or rivaroxaban.

3 randomization

You will be randomly assigned to receive either the investigational therapy or a placebo. This process is double-blind, meaning neither you nor the medical staff will know which treatment you receive.

4 administration of treatment

If you are in the interventional group, you will receive an intravenous infusion of alteplase or a placebo. This should start within 4.5 hours from the onset of stroke symptoms, but can be extended to 6 hours if clinically justified.

5 monitoring and follow-up

Your condition will be monitored closely, with assessments using the National Institutes of Health Stroke Scale (NIHSS) at admission and after 7 days. The modified Rankin Scale (mRS) will be used to evaluate your functional outcome at 90 days.

6 completion of study

The study will conclude with a final assessment of your recovery and any side effects experienced. This information will contribute to understanding the efficacy and safety of the treatment.

Who Can Join the Study?

Provide your consent to participate in the study. If you cannot sign due to a severe neurological issue, you can give oral consent, which must be confirmed by two independent witnesses or your legal representative.
Be over 18 years old.
Have a clinical diagnosis of acute ischemic stroke, which means a sudden blockage of blood flow to the brain causing a disabling neurological problem.
Be on a specific type of blood thinner called a non-vitamin K antagonist oral anticoagulant (such as apixaban or rivaroxaban) with a confirmed blood level above a certain threshold.
Be able to start the study treatment (either the actual treatment or a placebo) within 4.5 hours of the stroke symptoms starting or the last time you were seen without symptoms. In some cases, this can be extended to 6 hours.

Who Cannot Join the Study?

Patients who have had a recent bleeding event. This means any significant loss of blood from the body.
Patients with a history of allergic reactions to the study medication. An allergic reaction is when the body reacts negatively to a substance, causing symptoms like rash or difficulty breathing.
Patients with severe liver disease. The liver is an organ that helps process substances in the body, and severe disease means it is not working well.
Patients with uncontrolled high blood pressure. This means blood pressure that is consistently too high and not managed by medication or lifestyle changes.
Patients who are pregnant or breastfeeding. This refers to women who are expecting a baby or are feeding a baby with breast milk.
Patients who have had a major surgery recently. Major surgery is a significant medical operation that requires recovery time.
Patients with a history of brain injury or brain surgery. This includes any past damage to the brain or operations performed on the brain.
Patients with severe kidney disease. The kidneys are organs that filter waste from the blood, and severe disease means they are not functioning properly.
Patients who are currently participating in another clinical trial. This means being involved in another study at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie	Rzeszow	Poland

Other Sites

Site Name	City	Country
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej	Wroclaw	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Wmncddoepvi Wjakmsotpfhccjhbdfyp Cbipuvz Oduaetfii I Txylikqxgbxcj Ih Mhodveyggfr W Lviek	Lodz	Poland
Uzztyewonnsdjq Ctzhkqt Kpgjaeoli	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	30.09.2021

Trial locations

Investigated drugs:

Recombinant Tissue Plasminogen Activator (rtPA) is a medication used to help dissolve blood clots. In this clinical trial, it is being tested for its ability to improve recovery in patients who have had an ischemic stroke, which is a type of stroke caused by a blood clot blocking blood flow to the brain. The medication is given through an intravenous (IV) line, meaning it is delivered directly into the bloodstream. The goal is to restore blood flow to the brain as quickly as possible to minimize damage and improve outcomes for patients.

Specific Reversal Agent (Antidote) is a medication used to counteract the effects of certain blood thinners, known as non-vitamin K antagonist oral anticoagulants (DOACs). These blood thinners are used to prevent blood clots, but in the case of a stroke, their effects need to be reversed to allow other treatments, like rtPA, to work effectively. The antidote is given to patients who are on these blood thinners to neutralize their effects, making it safer to administer the clot-dissolving medication and help restore normal blood flow to the brain.

Investigated diseases:

Ischaemic stroke

Acute ischemic stroke – Acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes. The progression of the disease can lead to sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. Other symptoms may include vision problems, dizziness, loss of balance, or severe headache. The severity and specific symptoms depend on the location and extent of the blockage in the brain. Immediate medical attention is crucial to minimize brain damage and potential complications.

Trial ID:

2024-518509-17-00

Protocol code:

NBK241/1/2020

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Use of Alteplase and Andexanet Alfa for Patients with Acute Ischemic Stroke on Non-Vitamin K Oral Anticoagulants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?