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Study on the Effects of Adenosine, Dipyridamole, and Apixaban in Patients with Takotsubo Syndrome

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What is this trial about?

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

This clinical trial is focused on studying a condition known as , often referred to as "broken heart syndrome." This condition can cause temporary heart muscle weakness, leading to symptoms similar to a heart attack. The study aims to explore the effects of different treatments on patients with this syndrome. One part of the study will investigate whether a combination of and can improve patient outcomes compared to the usual care. is a substance that can help regulate heart rhythm, while is a medication that helps prevent blood clots by keeping blood vessels open.

Another part of the study will examine if , a medication that helps prevent blood clots, can reduce the risk of clot-related events such as strokes or heart attacks in patients with . Participants in this study will be randomly assigned to receive either the study medications or a placebo, which is a substance with no active ingredients. The study will monitor participants over a period of up to 30 days to assess the effects of the treatments on heart function and the occurrence of any heart-related events.

The goal of this research is to determine if these treatments can provide better outcomes for patients with by improving heart function and reducing the risk of complications. Participants will undergo regular check-ups and assessments to track their progress and ensure their safety throughout the study. The findings from this trial could help improve the management and treatment of this condition in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the clinical trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are 18 years or older and have a clinical diagnosis of Takotsubo Syndrome with an ejection fraction (EF) of less than 50% at baseline.

  3. Step 3

    Randomization 1

    You will be randomly assigned to receive either the standard care or a combination of adenosine and dipyridamole. Adenosine is administered through infusion, while dipyridamole is taken orally as a prolonged-release capsule.

  4. Step 4

    Randomization 2

    In this phase, you may be randomly assigned to receive apixaban or no antithrombotic treatment. Apixaban is taken orally as a film-coated tablet.

  5. Step 5

    Medication administration

    If assigned to receive adenosine and dipyridamole, adenosine will be given as an infusion, and dipyridamole will be taken orally. If assigned to receive apixaban, it will be taken orally as a tablet. The specific dosage and frequency will be provided by the study team.

  6. Step 6

    Monitoring and follow-up

    Your health will be monitored throughout the study. This includes regular assessments of your heart function, such as measuring the ejection fraction at 48-96 hours and checking for any thromboembolic events or cardiac complications up until day 30.

  7. Step 7

    End of study

    The study will conclude with a final assessment of your health and any outcomes related to the treatment. Long-term follow-up may occur at 6 months and annually for up to 10 years to monitor for any lasting effects or complications.

Who can join the trial?

3 criteria

  • Age must be 18 years or older.
  • Must have a clinical diagnosis of Takotsubo Syndrome, which includes having an ejection fraction (EF) of less than 50% at the start. Ejection fraction is a measurement of how well the heart is pumping blood.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who have a history of **Takotsubo syndrome** cannot participate. Takotsubo syndrome is a temporary heart condition often brought on by stress.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have any other medical condition that the study doctors think would make it unsafe for them to participate cannot join the study.
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Investigated drugs

  • Adenosine

    is a medication that helps to improve blood flow to the heart. In this trial, it is being used to see if it can help patients with Takotsubo Syndrome, a condition often referred to as "broken heart syndrome," by improving their heart function and overall health outcomes.

  • Dipyridamole

    is a medication that works by keeping adenosine in the bloodstream longer, which can help improve blood flow to the heart. In this study, it is used alongside adenosine to see if the combination can provide better results for patients with Takotsubo Syndrome compared to the usual treatments.

  • Apixaban

    is a medication that helps prevent blood clots. In this trial, it is being tested to see if it can reduce the risk of blood clot-related events in patients with Takotsubo Syndrome, compared to not using any blood-thinning medications.

What is already known about the treatment

  • Adenosine

    Adenosine is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied for its potential benefits in treating Takotsubo syndrome, a condition often referred to as "broken heart syndrome." The main therapeutic use of adenosine in this context is to improve heart function and outcomes in affected patients. At the molecular level, adenosine works by binding to specific receptors in the heart, which can help regulate heart rhythm and improve blood flow. It is classified as an antiarrhythmic agent, which means it helps manage irregular heartbeats.

  • Dipyridamole

    Dipyridamole is taken orally in the form of a tablet. It is being investigated for its role in enhancing the effects of adenosine in patients with Takotsubo syndrome. The primary therapeutic indication for dipyridamole in this study is to support heart function by preventing the reuptake of adenosine, thereby increasing its availability and effectiveness. On a molecular level, dipyridamole inhibits the uptake of adenosine into cells, prolonging its action. It is classified as a vasodilator and antiplatelet agent, which means it helps widen blood vessels and prevent blood clots.

  • Apixaban

    Apixaban is an oral medication, typically taken as a tablet. It is being evaluated for its ability to reduce the risk of blood clots in patients with Takotsubo syndrome. The main therapeutic use of apixaban in this trial is to prevent thromboembolic events, which are dangerous blood clots that can travel through the bloodstream. Apixaban works by inhibiting a specific factor in the blood clotting process, known as Factor Xa, which helps prevent the formation of clots. It is classified as an anticoagulant, commonly known as a blood thinner.

Investigated diseases

Takotsubo syndrome – Takotsubo syndrome is a temporary heart condition that often mimics a heart attack. It is characterized by sudden weakening of the heart muscle, leading to changes in the heart's shape and function. The condition is often triggered by severe emotional or physical stress. During the syndrome, the heart's main pumping chamber, the left ventricle, changes shape, resembling a Japanese octopus trap, which is where the name "Takotsubo" comes from. Symptoms can include chest pain, shortness of breath, and irregular heartbeats. The heart muscle typically recovers its normal function over time, but the condition can lead to complications if not monitored.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501874-21-00Protocol codeBROKEN-SWEDEHEARTEstimated enrolment1 600 patientsSponsorVaestra Goetalandsregionen

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).