A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery...
Venous ThromboembolismThe primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin The secondary objectives of the study are: To evaluate the bleeding risk (ie, major and clinically relevant non-major [CRNM] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin To assess overall safety and tolerability of REGN9933 in participants undergoing TKA To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways To assess immunogenicity following a single dose of REGN9933 over time To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary...
Pulmonary EmbolismEmbolism7 moreThe clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous...
CancerVenous Thromboembolism1 moreCancer patients that develop blood clots are treated with low molecular weight heparin injections (LMWH). One kind of these LMWHs, dalteparin, has its dose determined based on a patient's weight using a formula of 200 international units (IU) per kilogram (kg). The current dosing of dalteparin approved by Health Canada has a maximum daily dose of 18 000 IU/day which is weight-adjusted for patients up to 90 kg. Any patient weighing more than 90 kg would take the same dosage regardless of their weight. The aim of this study is to assess the safety of using weight-adjusted dalteparin in cancer-associated venous thromboembolism patients that weigh more than 90 kg.
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism...
Venous ThromboembolismApixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE.
Statins for Venous Event Reduction in Patients With Venous Thromboembolism
Venous ThromboembolismBlood Clot1 moreThe standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants). While treatment of blood clots with blood thinners is effective, some research has shown that adding a statin (medication used to lower cholesterol) may give extra protection. It is thought that statins can improve how cells along the walls of the vein control inflammation, which can prevent new blood clots from forming. The medication in this study, rosuvastatin, is approved in Canada for use as a cholesterol-lowering medication. The use of rosuvastatin in this study is considered investigational. This means that Health Canada has not approved the use of rosuvastatin as a treatment for blood clots. However, it has been approved for use in this research study. The purpose of this study is to examine if adding a statin (rosuvastatin) to the usual blood thinner treatment will decrease the risk of another blood clot forming. The investigators also hope to discover if taking a statin reduces damage to your veins. To do this, some of the participants in this study will get rosuvastatin and others will receive a placebo (a substance that looks like the study rosuvastatin but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on your blood clot. A placebo is used to make the results of the study more reliable.
BPA in CTEPD Without PH
Chronic Thromboembolic DiseaseThe goal of this clinical trial is to assess the effect of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients with chronic tromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH). The main question[s] it aims to answer are: What is the effect of BPA on quality of life, measured with the PEmb-QoL-questionnaire, in patients with CTEPD without PH? What is the effect of is the effect of BPA on exercise capacity in patients with CTEPD without PH? This study is a randomised clinical trial with cross-over design. Participants will be randomised in an intervention and a control group. At baseline, questionnaires and exercise tests will be perfomed in all patients. The intervention group will first receive BPA-treatment. After 6 months, all patients will fill in the questionaires and undergo the exercise tests. At this point the control group will also receive BPA-treatment. After 12 months the study outcomes will be measured in all participants with the same questionnaires and exercise tests. The total follow-up is 24 months.
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Venous ThromboembolismTo assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Study of Low Molecular Weight Heparins
AnticoagulantVenous Thromboembolism2 moreDANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently used parenteral anticoagulants in Denmark, include the two different low molecular weight heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is a lack of evidence regarding whether these drugs are in fact comparable. The aim of this study is therefore to investigate the comparative safety and efficacy of the two different low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in patients with an indication for low molecular weight heparins.
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
Nephrotic SyndromeThromboembolic DiseaseThe study aims to describe the biochemical coagulation profile and investigate the effect of Low molecular weight heparin and Apixaban on this profile in patients with nephrotic syndrome.
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer...
Venous ThromboembolismDeep Venous Thrombosis1 moreThis is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)