This clinical trial is focused on studying a condition known as venous thromboembolism (VTE), which involves the formation of blood clots in the veins. The study is particularly interested in patients who have VTE associated with cancer. Two treatments are being compared in this trial: Abelacimab, a solution for infusion, and Apixaban, a film-coated tablet. Abelacimab is administered through an infusion, which means it is given directly into the bloodstream, while Apixaban is taken orally as a tablet.
The purpose of the study is to evaluate whether Abelacimab is as effective as Apixaban in preventing the recurrence of VTE in patients with cancer over a period of six months. If Abelacimab proves to be at least as effective, the study will further assess if it might be even better. Participants in the study will receive either Abelacimab or Apixaban and will be monitored for any recurrence of VTE and any bleeding events during the six-month period.
This trial is designed to provide valuable information on the effectiveness and safety of these treatments for patients with cancer-related VTE. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered, but the evaluation of the results is blinded to ensure unbiased assessment. The trial aims to help improve treatment options for patients dealing with this serious condition.
1randomization
Upon joining the study, participants are randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment being studied.
2treatment with abelacimab
Participants in this group receive abelacimab, which is administered as a 150 mg/ml solution for infusion. This medication is given through a subcutaneous injection, which means it is injected under the skin.
The treatment aims to prevent the recurrence of venous thromboembolism (VTE) in patients with cancer.
3treatment with apixaban
Participants in this group receive apixaban, known by the brand name Eliquis, in the form of 5 mg film-coated tablets. This medication is taken orally, meaning it is swallowed.
The treatment is designed to prevent the recurrence of venous thromboembolism (VTE) in patients with cancer.
4treatment duration
Both treatments are administered for a period of 6 months. During this time, the effectiveness of each medication in preventing VTE recurrence is evaluated.
5evaluation of outcomes
The primary outcome measured is the time to the first event of VTE recurrence, which is centrally adjudicated, meaning it is assessed by a central committee to ensure accuracy and consistency.
This evaluation occurs throughout the 6-month treatment period.
Who Can Join the Study?
Must be a male or female who is at least 18 years old or the legal age of maturity in their country.
Must have a confirmed diagnosis of cancer, which means the cancer has been identified through a tissue sample or imaging tests. This does not include only basal-cell or squamous-cell skin cancer. The cancer should be active, meaning it is growing locally, spreading to nearby areas, or has spread to other parts of the body. Alternatively, the patient should be currently receiving or have received cancer treatment like radiation, chemotherapy, hormone therapy, or any other cancer treatment in the last 6 months.
Must have a confirmed case of venous thromboembolism (VTE), which is a condition where blood clots form in the veins. This includes clots in the deep veins of the lower leg (like the popliteal, femoral, iliac, or inferior vena cava veins) or a pulmonary embolism (PE), which is a clot in the lung arteries. The patient should be eligible within 120 hours (5 days) from the diagnosis of the VTE.
Must be indicated for anticoagulation therapy, which is treatment to prevent blood clots, with a therapeutic dose of DOAC (a type of blood thinner) for at least 6 months.
Must be able to provide written informed consent, meaning they understand the study and agree to participate.
Who Cannot Join the Study?
Patients who have a history of venous thromboembolism (VTE), which is a condition where blood clots form in the veins.
Patients who are not within the specified age range for the study.
Patients who do not belong to the specific clinical trial group required for the study.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, meaning they might need special protection or care.
Abelacimab is a medication being studied to see if it can prevent blood clots from coming back in patients who have cancer and have recently had a blood clot. The study is looking to see if abelacimab is at least as good as another medication in preventing these clots over a period of six months.
Apixaban is a medication that is already used to prevent blood clots from forming or getting worse. In this study, it is being used as a comparison to see how well abelacimab works in preventing blood clots in patients with cancer.
Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, which can lead to complications if the clots travel to other parts of the body. It typically begins with a clot in a deep vein, often in the legs, known as deep vein thrombosis (DVT). If a part of this clot breaks off, it can travel to the lungs, causing a pulmonary embolism (PE). Symptoms may include swelling, pain, and redness in the affected area, as well as shortness of breath and chest pain if a PE occurs. The progression of VTE can vary, with some individuals experiencing recurrent episodes. It is important to monitor and manage the condition to prevent further complications.
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