Clinical Trials for Thrombosis Prophylaxis
This article describes 3 ongoing clinical trials investigating different approaches to preventing blood clots in various patient groups. These studies are examining medications including apixaban, asundexian, tinzaparin, and dalteparin in conditions ranging from atrial fibrillation to multiple myeloma, knee replacement surgery, and venous thromboembolism.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- Espagne
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Spain
- Sweden
Study on Apixaban for Blood Clot Prevention in New Multiple Myeloma Patients and Those Having Knee Replacement Surgery
This study examines how the blood-thinning medication apixaban affects thrombin generation in two distinct patient groups who are at risk of developing blood clots. The trial compares patients with newly diagnosed multiple myeloma, a type of blood cancer, with patients undergoing total knee replacement surgery.
Who can participate: The study is open to adults over 18 years of age who have provided informed consent and are covered by health insurance. Participants must fall into one of two groups: those with newly diagnosed multiple myeloma who have not yet received chemotherapy and whose treatment plan includes apixaban for clot prevention, or those scheduled for total knee replacement surgery with apixaban prescribed as part of their care plan.
Who cannot participate: Patients who have already started chemotherapy for multiple myeloma are excluded, as are those who have not undergone the specific knee replacement surgery. The study also excludes individuals outside the specified age range and those considered part of vulnerable populations who may require special protection.
Study focus: The main goal is to understand how apixaban influences thrombin generation, a key process in blood clotting, in these two different patient populations. Researchers will measure the endogenous thrombin potential in blood samples collected at specific times after medication administration. For multiple myeloma patients, the study will also evaluate how the medication’s effects change after several cycles of chemotherapy. Blood samples will be collected at various time points over a 12-hour period to track how the body processes the medication.
Investigational drug: Apixaban is administered as a 2.5 mg oral tablet. It works by inhibiting factor Xa, a substance in the blood that plays a crucial role in clot formation. By blocking this factor, apixaban reduces the blood’s ability to form clots, thereby helping prevent thromboembolism in at-risk patients.
Study on Asundexian and Apixaban for Preventing Stroke in Adults with Atrial Fibrillation at Risk for Stroke
This large international trial investigates whether a new medication called asundexian is at least as effective as the established drug apixaban in preventing stroke and systemic embolism in people with atrial fibrillation, a heart rhythm disorder that increases stroke risk.
Who can participate: Adults aged 18 or older with atrial fibrillation confirmed by an ECG test are eligible. Participants must have a CHA2DS2-VASc score of 3 or higher for males or 4 or higher for females, which indicates an elevated risk of stroke. Lower scores may also qualify if additional criteria are met.
Who cannot participate: The study excludes patients with a history of bleeding disorders, severe liver disease, kidney disease requiring dialysis, or a stroke within the past 6 months. Those with uncontrolled high blood pressure, pregnant or breastfeeding women, individuals currently in another clinical trial, and those with known allergies to the study medications are also ineligible.
Study focus: The primary objective is to determine whether asundexian is non-inferior to apixaban in preventing stroke or systemic embolism while assessing the risk of major bleeding, a significant concern with blood-thinning medications. This is a double-blind, randomized study, meaning neither participants nor researchers know who receives which treatment, ensuring unbiased results. The study will also monitor other outcomes including minor bleeding, cardiovascular events, and overall mortality. Participants will be followed for up to 33 days with regular monitoring visits.
Investigational drugs: Asundexian is an experimental FXIa inhibitor that blocks a specific protein involved in blood clot formation. It is being compared to apixaban, an established anticoagulant that prevents blood clots by blocking factor Xa in the clotting process. Both medications are taken orally as film-coated tablets, with apixaban available in 5 mg and 2.5 mg doses.
Study on Tinzaparin and Dalteparin for Patients with Venous Thromboembolism
This Danish study compares two low molecular weight heparins, tinzaparin and dalteparin, in hospitalized patients with venous thromboembolism, a condition where blood clots form in the veins and can travel to the lungs.
Who can participate: All hospitalized patients of any age who require treatment with low molecular weight heparin are eligible, regardless of gender. Patients will only be included during their first admission within the study period. The study is inclusive of vulnerable populations who may need special care or protection.
Who cannot participate: Patients with a history of bleeding disorders, those currently taking other anticoagulant medications, and individuals with severe liver or kidney disease are excluded. Pregnant or breastfeeding women, recent surgical patients, those with known heparin allergies, patients with uncontrolled high blood pressure, a history of stroke, or active cancer are also ineligible.
Study focus: The trial evaluates whether treatment with these blood thinners affects the risk of bleeding that requires medical attention or leads to death within 30 days of starting treatment. Researchers will monitor various health indicators including the need for blood transfusions, occurrence of pulmonary embolism, signs of heparin-induced thrombocytopenia (a condition causing low platelet counts), overall survival rates, and length of hospital stays. The medications are administered through subcutaneous injection, meaning they are injected under the skin.
Investigational drugs: Both tinzaparin and dalteparin are low molecular weight heparins that work by enhancing the activity of a natural protein in the body that prevents clotting. This makes the blood less likely to form clots. These medications are well-established anticoagulants primarily used to prevent and treat blood clots in conditions like venous thromboembolism.
Summary
These three clinical trials represent diverse approaches to preventing dangerous blood clots in different patient populations. The studies are geographically concentrated in Europe, with the atrial fibrillation trial being the most widely distributed across 23 countries including Slovakia, Romania, Netherlands, Poland, and many others throughout Western, Northern, and Eastern Europe. The French study focuses on multiple myeloma and orthopedic surgery patients, while the Danish trial examines venous thromboembolism treatment in hospitalized patients.
A notable pattern is the focus on apixaban, which appears in two of the three studies. The atrial fibrillation trial is particularly significant as it tests a new medication, asundexian, against the established apixaban, potentially offering an alternative with a different mechanism of action that might reduce bleeding risk. The multiple myeloma and knee replacement study explores how apixaban works differently in these distinct patient groups, which could lead to more personalized treatment approaches.
The Danish study takes a different approach by comparing two established low molecular weight heparins, focusing on real-world safety outcomes in hospitalized patients. All three trials prioritize understanding the delicate balance between preventing dangerous blood clots and avoiding serious bleeding complications, which is the central challenge in anticoagulation therapy.
