Clinical Trials for Venous Thromboembolism: Current Treatment Studies
Venous thromboembolism is a serious condition where blood clots form in the veins, potentially leading to complications if the clots travel to the lungs. Currently, there are 7 ongoing clinical trials exploring various treatments to prevent and manage this condition, including new medications and different approaches to blood-thinning therapy. These studies are taking place across multiple European countries and involve both established and investigational drugs.
Clinical trial locations
- Austria
- Czechia
- Denmark
- Finland
- France
- Germany
- Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer
- Evaluation of a Single Measurement Strategy for Direct Oral Anticoagulants in Frail Older Patients with Atrial Fibrillation or Venous Thromboembolism
- Study Comparing Abelacimab and Apixaban for Preventing Blood Clots in Cancer Patients
- Hungary
- Ireland
- Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer
- Study Comparing Bleeding Risk of Rivaroxaban and Apixaban in Patients with Acute Venous Thromboembolism
- Study Comparing Abelacimab and Apixaban for Preventing Blood Clots in Cancer Patients
- Italy
- Latvia
- Netherlands
- Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer
- Study on Venous Thromboembolism Prevention with Enoxaparin Sodium and Drug Combination for Patients Undergoing Total Hip or Knee Replacement
- Evaluation of a Single Measurement Strategy for Direct Oral Anticoagulants in Frail Older Patients with Atrial Fibrillation or Venous Thromboembolism
- Study Comparing Abelacimab and Apixaban for Preventing Blood Clots in Cancer Patients
- Norway
- Spain
- Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary-cancer/”>Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer
- Study Comparing Abelacimab and Apixaban for Preventing Blood Clots in Cancer Patients
- Sweden
Study on Abelacimab and Dalteparin for Preventing Blood Clots in Patients with Gastrointestinal or Genitourinary Cancer
This trial is comparing two treatments for preventing blood clots in cancer patients: abelacimab, a new medication, and dalteparin, an established treatment. The study focuses on patients with gastrointestinal or genitourinary cancers who have recently developed blood clots.
Who can participate: Participants must be adults aged 18 or older with confirmed gastrointestinal or genitourinary cancer. This includes cancers of the colon, pancreas, stomach, esophagus, liver, kidneys, bladder, prostate, or urethra. The cancer must be either not removable by surgery, locally advanced, or spread to other parts of the body. Participants must have a recently confirmed deep vein thrombosis in the upper leg or pulmonary embolism, diagnosed within the last 5 days. They must need anticoagulation therapy with low molecular weight heparin for at least 6 months and be able to provide written informed consent.
Who cannot participate: Patients without gastrointestinal or genitourinary cancer, those not recently diagnosed with blood clots, patients outside the specified age range, those unable to follow study procedures, patients with other interfering medical conditions, pregnant or breastfeeding women, those participating in another trial, and patients with allergic reactions to study medications are excluded.
Treatment approach: Participants receive either abelacimab administered through subcutaneous injection or dalteparin through subcutaneous injection for 6 months. The study monitors the recurrence of blood clots and any bleeding events during this period.
Investigational drugs: Abelacimab is being studied to see if it can prevent blood clots from returning as effectively as dalteparin. Abelacimab works by inhibiting Factor XI, a protein involved in blood clotting. Dalteparin is an established medication that enhances the activity of antithrombin to prevent clot formation.
Study on Apixaban for Preventing Blood Clots in Patients Undergoing Abdominal, Gynecologic, and Urologic Surgery
This trial investigates whether apixaban, an oral anticoagulant, can safely prevent blood clots in patients undergoing abdominal, gynecologic, and urologic surgeries without causing significant bleeding complications.
Who can participate: Participants must be adults aged 18 or older undergoing abdominal or pelvic surgery with a similar and not high risk of developing blood clots and bleeding. Both male and female patients can participate, and informed consent is required.
Who cannot participate: Patients at high risk of bleeding or blood clots, those not undergoing the specified types of surgery, patients outside the age range, and those belonging to vulnerable populations are excluded.
Treatment approach: Participants are randomly assigned to receive either apixaban or no anticoagulant treatment. Both groups receive standard care including mechanical methods like compression stockings. The study monitors blood clot occurrence and bleeding complications over 90 days after surgery.
Investigational drugs: Apixaban is an oral anticoagulant that works by inhibiting factor Xa, reducing the risk of blood clot formation. The study aims to determine if apixaban provides benefits in preventing blood clots without increasing bleeding risk.
Study on Venous Thromboembolism Prevention with Enoxaparin Sodium and Drug Combination for Patients Undergoing Total Hip or Knee Replacement
This trial compares different approaches to preventing blood clots in patients undergoing total hip or knee replacement surgery, including a personalized method versus the standard approach.
Who can participate: Patients must be scheduled for elective total hip or knee replacement surgery and be 18 years or older. Both men and women can participate, and patients should not be part of a vulnerable population.
Who cannot participate: Patients with a history of blood clots, those outside the specified age range, patients not part of the specified trial group, and those considered part of a vulnerable population are excluded.
Treatment approach: Participants are randomly assigned to different prevention approaches using various anticoagulant medications including enoxaparin sodium, nadroparin calcium, apixaban, and rivaroxaban. The study monitors blood clot occurrence and major bleeding events for three months after surgery.
Investigational drugs: The study uses thrombosis prophylaxis therapy to prevent blood clots, investigating whether a personalized approach is as effective as the standard method. Various medications help prevent clots by thinning the blood or reducing clotting risk.
Evaluation of a Single Measurement Strategy for Direct Oral Anticoagulants in Frail Older Patients with Atrial Fibrillation or Venous Thromboembolism
This study evaluates whether measuring and adjusting levels of direct oral anticoagulants in frail older patients can reduce complications such as bleeding or blood clots.
Who can participate: Participants must be over 70 years old, currently using a DOAC medication, have a Clinical Frailty Scale score greater than 3, be able to visit the outpatient clinic if living in the community, and provide informed consent. They must have atrial fibrillation or blood clots in veins.
Who cannot participate: Patients under 75 years, those without atrial fibrillation or blood clots, patients not taking DOACs, those not considered frail, patients with severe kidney failure, active cancer requiring treatment, life expectancy less than 1 year, inability to provide consent, pregnancy or breastfeeding, recent trial participation, known allergies to study medications, or active bleeding are excluded.
Treatment approach: Participants are randomly assigned to standard care or an intervention group where DOAC levels are measured and dosage adjusted if needed. The study monitors blood clots, bleeding events, and quality of life throughout the follow-up period.
Investigational drugs: Direct oral anticoagulants are blood-thinning medications that work by inhibiting specific proteins involved in blood clotting. They include medications like apixaban, rivaroxaban, edoxaban, and dabigatran.
Study Comparing Abelacimab and Apixaban for Preventing Blood Clots in Cancer Patients
This trial compares abelacimab and apixaban to determine which is more effective at preventing blood clot recurrence in cancer patients over six months.
Who can participate: Participants must be at least 18 years old with confirmed cancer diagnosis, excluding only basal-cell or squamous-cell skin cancer. The cancer should be active or participants should be receiving or have received cancer treatment in the last 6 months. They must have confirmed blood clots diagnosed within the last 5 days and need anticoagulation therapy for at least 6 months.
Who cannot participate: Patients with a history of blood clots, those outside the specified age range, patients not belonging to the specific trial group, and those considered part of a vulnerable population are excluded.
Treatment approach: Participants receive either abelacimab through subcutaneous injection or apixaban as oral tablets for 6 months. The study monitors blood clot recurrence and bleeding events during this period.
Investigational drugs: Abelacimab works by inhibiting Factor XI in the blood clotting process. Apixaban inhibits Factor Xa, an enzyme crucial for converting prothrombin to thrombin, thereby reducing clot formation.
Study Comparing Bleeding Risk of Rivaroxaban and Apixaban in Patients with Acute Venous Thromboembolism
This trial compares the safety of rivaroxaban and apixaban in treating acute blood clots, focusing on which medication causes fewer bleeding complications.
Who can participate: Participants must have symptomatic acute blood clots, including deep vein thrombosis in the upper leg or pulmonary embolism affecting a significant part of the lung. They must be 18 years or older, understand the study information, and provide signed consent. Women of childbearing potential must use effective contraception and have a negative pregnancy test.
Who cannot participate: Patients with allergic reactions to study medications, those currently taking other blood thinners, patients with severe liver disease, kidney problems requiring dialysis, pregnant or breastfeeding women, patients with bleeding disorders, recent major surgery, uncontrolled high blood pressure, history of stroke, or cancer not in remission are excluded.
Treatment approach: Participants are randomly assigned to receive either rivaroxaban or apixaban as oral tablets for up to three months. The study monitors bleeding events, blood clot recurrence, and overall survival rates.
Investigational drugs: Rivaroxaban and apixaban both work by blocking proteins involved in blood clotting. Rivaroxaban and apixaban inhibit Factor Xa, a key protein in the clotting process, helping prevent harmful clot formation.
Study on Tinzaparin and Dalteparin for Patients with Venous Thromboembolism
This trial compares two types of low molecular weight heparins, tinzaparin and dalteparin, to evaluate their safety in preventing blood clots in hospitalized patients.
Who can participate: Patients must be admitted to the hospital and have a medical need for treatment with low molecular weight heparin. Patients will only be included the first time they are admitted during the study period. Both male and female patients of all age groups can participate, including those who may be considered part of a vulnerable population.
Who cannot participate: Patients with bleeding disorders, those currently taking other anticoagulant medications, patients with severe liver or kidney disease, pregnant or breastfeeding women, those who had recent surgery, patients with known heparin allergies, uncontrolled high blood pressure, history of stroke, or active cancer are excluded.
Treatment approach: Participants are randomly assigned to receive either tinzaparin or dalteparin through subcutaneous injection. The study monitors for major bleeding events or other health outcomes within 30 days of starting treatment.
Investigational drugs: Low molecular weight heparins are medications that thin the blood by enhancing the activity of a natural protein that helps prevent clotting. The study evaluates whether these medications might increase bleeding risk requiring medical attention.
Summary
The seven ongoing clinical trials for venous thromboembolism represent a diverse approach to managing this serious condition. Several notable patterns emerge from these studies. Multiple trials are investigating abelacimab, a newer medication, suggesting significant research interest in this Factor XI inhibitor as an alternative to established treatments. Two large multinational trials are comparing abelacimab against standard treatments specifically in cancer patients across multiple European countries.
There is a clear focus on cancer-associated blood clots, with three trials specifically targeting this patient population. This reflects the increased risk of blood clots in cancer patients and the need for effective prevention strategies. The trials span various clinical scenarios, including treatment of existing clots, prevention after surgery, and management in frail elderly patients.
Geographically, the trials are concentrated in Western and Northern Europe, with the Netherlands, Germany, Ireland, Austria, and several other countries participating in multiple studies. Some trials are single-country studies in Finland, Denmark, and Ireland, while others involve extensive multinational collaboration across up to 12 countries.
The studies employ both established direct oral anticoagulants like apixaban and rivaroxaban, as well as traditional low molecular weight heparins. The comparison of different medication classes and personalized dosing strategies suggests the field is actively seeking to optimize treatment approaches for different patient populations, particularly those at higher risk such as cancer patients, surgical patients, and frail elderly individuals.
