Clinical Trials
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Thrombosis
Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy
Apr 2013This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.
Satisfaction/Quality of Life With Rivaroxaban in DVT (Deep Venous Thrombosis) Indication (SATORI)
Mar 2013National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer
Feb 2013The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.
Study on the Clinical Course Of Pulmonary Embolism (SCOPE)
Jan 2013The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown. Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient. Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims: - to ascertain the actual incidence of symptomatic CTEPH after a first episode of acute PE; - to ascertain the actual incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE; - to evaluate whether a relation exists between chronic residual PE and CTEPH - to evaluate whether a relation exists between chronic residual PE and VTE recurrences; - to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH; - to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences. For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.
Funen's strategy in the prevention of Blood clots in critically ill patients with acute kidney Injury
Oct 2012To reduce the incidence of venous thromboembolism(VTE) among patients on continuous renal replacement therapy (CRRT) by using 1 mg/kg enoxaparin, versus the standard dose of 40 mg enoxaparin.
An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee Arthroplasty
Oct 2012• To assess the safety and efficacy profile of ISIS 416858, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty • To assess a potential dose-response relationship of ISIS 416858 with respect to the reduction of VTE incidence in patients undergoing total knee arthroplasty
30 day, open-label, active-controlled, randomized study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis
Sep 2012The primary objective is to assess the incidence of major bleeding and clinically relevant non-major bleeding
Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy (XALIA)
May 2012Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection
May 2012This study plans to learn more about the role of 2 blood tests in predicting who might develop a blood clot in their arm or leg after major surgery. The investigators know that patients who have cancer and major surgery have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous because the clot can move into your lungs.
A randomized pilot study comparing the safety of DAbigatran and RIvaroxaban versus NAdroparin in the prevention of venous thromboembolism after knee arthroplasty surgery. DARINA
May 2012After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty. Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA)
Pro-coagulant Markers and Anticoagulant Failure in Cancer Patients at High-risk for Recurrence of Venous Thromboembolism
May 2012The presence of clots in the veins of arms and/or legs or lungs of Cancer patients decreases their quality of life, delays their treatment and may cause death. The best way to avoid new clots is by giving blood thinners before clots are formed, but even some patients who are taking blood thinners may form blood clots. A major problem is that it is difficult to know which patients form clots while they are receiving blood thinners, a situation called treatment failure. Several studies have shown that by doing blood tests that measure the formation of clots, the investigators could know if the patient is responding to the blood thinners. If this is proven, the investigators will be able to apply these tests to all patients
Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients
May 2012Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli) which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients without blood clots. Blood thinners may prevent clots but major bleeding is also a problem, so preventive therapies are not used routinely. Identifying patients at highest risk for clots is critical. A tool exists but it has not been used outside of research. We propose to study how to apply this tool in clinical practice and test if it works.
Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients
May 2012Demonstrate the superiority of extended duration (35 days + 7 day window, i.e. 35-42 days allowed) anticoagulation with betrixaban as compared to the standard of care (10 ± 4 days) with enoxaparin for prevention of VTE in patients who are at risk due to acute medical illness
Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients
May 2012Demonstrate the superiority of extended duration (35 days + 7 day window, i.e. 35-42 days allowed) anticoagulation with betrixaban as compared to the standard of care (10 ± 4 days) with enoxaparin for prevention of VTE in patients who are at risk due to acute medical illness
Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism
Mar 2012The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.
Superficial vein thrombosis (SVT) treated for forty-five days with Rivaroxaban versus Fondaparinux
Dec 2011Evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major VTE complications to prove non-inferiority of oral rivaroxaban treatment
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery (DARINA)
Sep 2011The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneous administered nadroparin by observing the incidence of major bleeding and clinical relevant non-major bleeding in patients after knee arthroplasty surgery.
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Sep 2011The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) (ROCITP2)
May 2011This multicentre, prospective cohort study aims to test the following hypotheses: - Antepartum prophylaxis with fixed-dose low molecular-weight heparin (LMWH) is safe, convenient and associated with an acceptably low risk of recurrent VTE in women with a single prior episode of VTE that was either unprovoked or associated with a minor transient risk factor. (Moderate risk cohort) - Withholding antepartum prophylaxis is safe (recurrence risk <1%) in pregnant women with a single prior episode of VTE provoked by a major transient risk factor. (Low risk cohort)
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery
Mar 2011The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endorcris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in Patients With High-Risk to Develop Thromboembolic Disease Undergoing Geral Abdominal Surgery.
PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot
Jan 2011The purpose of this study is to determine if it is feasible to conduct a multi-center randomized trial with a placebo control to determine whether a blood thinner, low-molecular-weight-heparin (LMWH), is effective at preventing blood clots, thromboembolism (VTE), in postpartum women at risk.
Multicentre, randomised, double blind, placebo controlled study on long-term treatment with Sulodexide for prevention of recurrent DVT in patients with venous thromboembolism
Nov 2010To determine whether Sulodexide is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for two years after the initial 3-12 months of oral anticoagulant therapy in patients with unprovoked (defined as not triggered by: major/orthopaedic surgery, immobilization due to setting for more than 4 days and due to plaster, major trauma) venous thromboembolism
A randomised controlled trial of extended warfarin treatment versus routine warfarin treatment for the prevention of recurrent venous thromboembolism and post thrombotic syndrome in patients being treated for a first episode of unprovoked VTE
Aug 2010The overarching objective of this study is to improve the prevention and treatment of recurrent VTE and post-thrombotic syndrome in patients being treated for a first episode of a proximal (above the knee) unprovoked blood clot.
An open label, non-comparative, pharmacokinetic and pharmacodynamic study to evaluate the effect of Dabigatran Etexilate on coagulation parameters including a calibrated thrombin time test in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery
Jun 2010To assess the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot® and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing primary unilateral elective total knee or hip replacement surgery.
Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
May 2010The primary objective of the study is to assess the efficacy of Innohep® in preventing the recurrence of Venous Thromboembolism(VTE) in patients with active cancer who have had an acute Venous Thromboembolism (VTE) episode.
Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism
Apr 2010The primary objective of this study is to investigate pharmacokinetics and pharmacodynamics of single oral doses of rivaroxaban in paediatric subjects in order to obtain weight adjusted doses with equivalent exposure compared to 10 mg and 20 mg doses in adults.
Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years.
Apr 2010This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE.
EUropean Pharmacogenetics of AntiCoagulation Therapy trial
Dec 2009The primary endpoint is the percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy. Our hypothesis is that pharmacogenetic guided dosing will increse the time within INR range if compared to non-pharmacogenetic guided dosing.
A phase 3, randomized, double-blind, double-dummy, parallel-group, multi-center, multi-national study for the evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism
Nov 2009Reduction of the risk of symptomatic recurrent venous thromboembolic complications in patients with acute symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Improving the safety and efficacy of anticoagulation therapy for thromboembolic disease through vitamin K
Oct 2009Warfarin inhibits the activation of clotting factors by inhibiting the regeneration of vitamin K in the vitamin K cycle. Patients anticoagulated with warfarin are very sensitive to intake of vitamin K. We have demonstrated that daily supplementation with 150 µg vitamin K of patients with unstable control significantly increased the time they spent in their therapeutic anticoagulation range. We hypothesise that daily supplementation with vitamin K would reduce bleeding and thromboembolism in the anticoagulated population and, as a pilot investigation to a multicentre study to assess this, aim to measure the impact of vitamin K on stability of control in an unselected anticoagulated cohort.
Long-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label study
Aug 2009To evaluate whether low-molecular-weight heparin (Enoxaparin, Dalteparine, Nadroparine, Tinzaparine) is superior to vitamin K antagonists (VKA) in the long-term treatment of symptomatic venous thromboembolism in cancer patients who have completed 6 to 12 months of anticoagulant treatment
Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
Aug 2009The goal of this clinical research study is to learn if dalteparin can lower the risk of venous thromboembolism (VTE) occurring in the legs and lungs.
Aspirin for the Prevention of Recurrent Venous Thromboembolism
May 2009To determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism
Venous Thromboembolism in Pregnancy Study (VIP)
Mar 2009The purpose of this study is to investigate clinical, biochemical and genetic risk factors for venous thromboembolism in pregnancy and pregnancy related vascular complications, and the long-term outcome of such complications including implications for quality of life.
An investigation of the association between vitamin K intake, vitamin K epoxide reductase subunit (VKORC1) genotype and anticoagulation response to warfarin
Feb 2009Our principal research objective is to assess this by exploring the inter−relationships between stability of anticoagulation control, dietary vitamin K intake and VKORC1 genotype. Vitamin K is necessary for the activation of clotting proteins normally needed to stop us from bleeding. Warfarin causes anticoagulation (blood−thinning) by inhibiting the vitamin K epoxide reductase (VKOR) enzyme responsible for the recycling of vitamin K in the liver. VKOR enzyme production is controlled by the vitamin K epoxide reductase gene (termed VKORC1). Some individuals can have mutations of the VKORC1 gene. These individuals produce VKOR enzyme with reduced activity. Vitamin K in the diet works in a directly opposite way to warfarin, counteracting the anticoagulation(blood thinning) response to warfarin. There are theoretical reasons, and a small amount of evidence to support that the antagonistic effect of dietary vitamin K might not be the same between patients with different genotypes.
Dalteparin Sodium Injection (Fragmin®), Multicenter, Open Label, Single-arm, Long Term (52 weeks) Study for Understanding Safety and Efficacy in Subjects with Malignancies and Symptomatic Venous Thromboembolism
Dec 2008The primary objective of the study is to determine the rate of major bleeing events in cancer patients receiving extended treatment with dalteparin ( more than 6 months and up to 12 months) for prevention of recurrent symptomatic venous thromboembolism (VTE).
Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism
Nov 2008The main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.
A safety and efficacy trial evaluating the use of apixaban for the extended treatment of deep vein thrombosis and pulmonary embolism (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY- EXTended treatment. The AMPLIFY-EXT study)
Jun 2008To determine if at least one of the apixaban dose regimens is superior to placebo in the combined endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death in subjects who have an objectively documented index event of symptomatic proximal DVT or symptomatic PE, have completed approximately 6 to 12 months of anticoagulant therapy for the treatment of the index event, and have no objectively documented symptomatic recurrence of VTE after the index event.
A Multinational, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery.
Jun 2008The primary objective of the study is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.) injections of 20 mg AVE5026 (10 mg in SRI patients) with q.d. s.c. injections of 40 mg enoxaparin (20 mg in SRI patients) administered during 7-10 days after surgery for the prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip replacement surgery.
ADOPT: Apixaban Dosing to Optimize Protection from Thrombosis. A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Mar 2008To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a minimum period of 6 days, in subjects with acute medical illness.
RE-NOVATE II: a phase III randomised, parallel group, double-blind, active controlled study to investigate the efficacy and safety of oral 220 mg dabigatran etexilate (110 mg on the day of surgery followed by 220 mg once daily) compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days in prevention of venous thromboembolism in patients following primary elective total hip arthroplasty.
Feb 2008The primary objective is to demonstrate the safety and efficacy of once daily 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily in preventing venous thromboembolism in patients following total hip replacement surgery.
The Einstein-Extension study. Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.
Feb 2008The primary efficacy objective is to evaluate whether rivaroxaban is superior to placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 14 months of treatment with vitamin K antagonist (VKA) outside of the Einstein VTE treatment program (study 11702) or who completed 6 or 12 months with VKA or rivaroxaban in the 11702 study.
Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.
May 2007For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic pulmonary embolism (PE) for the prevention of recurrent venous thromboembolic events. For the Einstein-PE evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic PE with or without symptomatic DVT for the prevention of recurrent venous thromboembolic events.
A phase IIb, randomized, parallel group, double blind, double-dummy, multi-center, multi national, multi-dose study of DU-176B compared to dalteparin in patients undergoing elective unilateral total hip replacement
Aug 2006The primary objective of this study is to assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE).
NOSTRADAMUS: Testing for thrombophilia in patients with a first episode of venous thromboembolism: a randomized controlled trial to assess effects on clinical outcomes, quality of life, and costs.
Jul 2006This study aims to assess efficacy and safety of testing for thrombophilia in patients with a first episode of VTE and subsequent additional anticoagulant treatment in those in whom thrombophilia is detected as compared to no testing and standard duration of therapy in all patients.
RE-MEDY, a phase III, randomised, multicenter, double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150 mg bid) compared to warfarin (INR 2.0-3.0) for the secondary prevention of venous thromboembolism.
May 2006To determine the comparative efficacy of dabigatran etexilate (150 mg bid) administered orally and warfarin (to maintain an INR of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic venous thromboembolism.
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