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Study on the Safety and Effectiveness of Apixaban, Edoxaban, and Phenprocoumon for Patients with Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty

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 clinical trial is focused on studying the effects of different anticoagulant medicines in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Chronic Thromboembolic Disease (CTED) without pulmonary hypertension. These conditions involve blood clots in the lungs that can lead to increased blood pressure in the lung arteries. The trial will compare the safety and effectiveness of two types of blood-thinning medications: Direct Oral Anticoagulants (DOACs) and Vitamin K Antagonists (VKAs). The medications being studied include Eliquis (apixaban), Fenprocoumon Sandoz (phenprocoumon), Lixiana (edoxaban), Acenocoumarol CF (acenocoumarol), Pradaxa (dabigatran etexilate), and Xarelto (rivaroxaban).

The purpose of the study is to evaluate how these medications perform in patients undergoing a procedure called Balloon Pulmonary Angioplasty (BPA). This procedure is used to open up blocked blood vessels in the lungs. The study will look at the occurrence of bleeding and lung injury within 24 hours after the procedure. Participants will receive one of the medications or a placebo, and their health will be monitored to see how well the medications work and how safe they are.

The study will take place over a period of time, with participants receiving treatment for up to 30 days. During this time, researchers will collect data on any complications, such as bleeding or lung issues, as well as other health outcomes like allergic reactions, kidney problems, and hospitalizations. The goal is to better understand which medication is most effective and safe for patients with CTEPH or CTED undergoing BPA.

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
Joining the study
Upon joining the study, the patient is confirmed to have a diagnosis of either Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension.
The patient must have been on anticoagulation treatment for at least three months and be considered inoperable, reluctant to undergo surgery, or have residual pulmonary hypertension after pulmonary endarterectomy.
Step 2
Medication administration
The patient will receive one of the following anticoagulant medications: Eliquis 2.5 mg film-coated tablets, Fenprocoumon Sandoz 3 mg tablets, Lixiana 15 mg, 30 mg, or 60 mg film-coated tablets, Acenocoumarol CF 1 mg tablets, Pradaxa 75 mg hard capsules, or Xarelto 2.5 mg film-coated tablets.
All medications are administered orally, except for one unspecified route for Lixiana 60 mg.
Step 3
Balloon pulmonary angioplasty (BPA)
The patient undergoes Balloon Pulmonary Angioplasty (BPA), a procedure to treat accessible thromboembolic lesions.
The main objective is to evaluate the safety and effectiveness of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in patients receiving BPA.
Step 4
Monitoring and evaluation
The patient is monitored for any periprocedural bleeding or lung injury within 24 hours after each BPA session.
Secondary evaluations include allergic reactions to contrast, renal dysfunction, venous thromboembolism, long-term bleeding complications, all-cause mortality, and non-scheduled hospitalization.
Step 5
Completion of the trial
The trial is estimated to conclude by November 30, 2026.
The patient's participation will contribute to understanding the safety and efficacy of anticoagulant treatments in the context of BPA.

Who can join the trial?

7 criteria

The patient must have a confirmed diagnosis of either Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension. These are conditions related to blood clots in the lungs.
The patient must have been on blood-thinning medication, known as anticoagulation treatment, for at least 3 months.
The patient should be unable to have surgery, unwilling to have surgery, or still have high blood pressure in the lungs after a surgery called Pulmonary Endarterectomy (PEA). They should be accepted for a treatment called Balloon Pulmonary Angioplasty (BPA).
The blood clots in the lungs must be reachable for the BPA treatment.
Both male and female patients can participate.
The study is open to adults, which typically means individuals aged 18 and older.
The study does not include vulnerable populations, which often refers to groups like children or those unable to give consent.

Who cannot join the trial?

4 criteria

Patients with medical conditions other than Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension cannot participate. Chronic Thromboembolic Pulmonary Hypertension (CTEPH) is a condition where blood clots block the blood vessels in the lungs, causing high blood pressure in the lungs. Chronic Thromboembolic Disease (CTED) is similar but without the high blood pressure.
Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Participants must be either male or female, as the study includes both genders.
Individuals who are considered part of a vulnerable population, such as those who may not be able to give informed consent, are not eligible to participate.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands
St. Antonius Ziekenhuis
Verified
Nieuwegein, The Netherlands

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Investigated drugs

DOAC
(Direct Oral Anticoagulant) is a type of medication used to prevent blood clots. In this trial, it is being evaluated for its safety and effectiveness in patients undergoing Balloon Pulmonary Angioplasty (BPA). The focus is on how well it prevents bleeding and lung injury during and after the procedure.
VKA
(Vitamin K Antagonist) is another type of blood-thinning medication. It is being compared to DOAC in this trial to see which is more effective and safer for patients with certain types of pulmonary hypertension undergoing BPA. The trial looks at the risk of bleeding and lung injury associated with its use.

What is already known about the treatment

Direct Oral Anticoagulants (DOACs)
These medications are taken orally and are currently being studied for their effectiveness and safety in treating patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension. They are well-documented in medical literature as alternatives to traditional anticoagulants. DOACs are primarily used to prevent blood clots and reduce the risk of stroke in patients with certain heart conditions. They work by directly inhibiting specific clotting factors in the blood, which helps to prevent the formation of harmful clots. DOACs are classified as anticoagulants and are known for their predictable effects and fewer dietary restrictions compared to other anticoagulants.
Vitamin K Antagonists (VKAs)
These medications are also taken orally and are being compared to DOACs in clinical trials for their use in patients undergoing Balloon Pulmonary Angioplasty for CTEPH and CTED. VKAs have been a standard treatment for preventing blood clots for many years and are well-established in medical practice. They work by inhibiting the action of vitamin K, which is necessary for the synthesis of certain clotting factors, thus reducing the blood's ability to clot. VKAs are classified as anticoagulants and require regular blood monitoring to ensure safe and effective dosing.

Investigated diseases

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
This disease is characterized by high blood pressure in the lungs' arteries due to unresolved blood clots. Over time, these clots can lead to scarring and narrowing of the pulmonary arteries, making it difficult for blood to flow through the lungs. As a result, the heart has to work harder to pump blood, which can lead to heart strain. Symptoms often include shortness of breath, fatigue, and chest pain. The condition can progress slowly, with symptoms worsening over time. It is a chronic condition that requires ongoing management.
Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension
This condition involves the presence of chronic blood clots in the lungs without the development of high blood pressure in the pulmonary arteries. Unlike CTEPH, CTED does not cause significant elevation in pulmonary artery pressure. However, it can still lead to symptoms such as shortness of breath and reduced exercise capacity. The disease progresses as the clots remain unresolved, potentially leading to lung function impairment. It is considered a chronic condition that may require monitoring and management to prevent complications.