View clinical trials related to Anticoagulants.
Filter by:The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years. So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants). This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450. Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.
Objectives Primary objective: To determine if rivaroxaban (Xarelto) is feasible and safe for prevention of major complications in patients undergoing a mechanical aortic heart valve replace-ment. Secondary objectives: To identify the value of molecular markers suitable for monitoring of anticoagulation effectiveness of rivaroxaban and its correlation with transcranial Doppler emboli count in patients undergoing a mechanical aortic heart valve replacement. Design This is a prospective, open-label phase 2 pilot study with independent evaluation of all outcomes and a historical control group. Number of patients 30 in experimental group (patients in the center's registry database serve as control group). Main eligibility criteria All patients between 18 and 70 years old receiving a mechanical aortic valve replacement with a pre-operative left ventricular ejection fraction >/=35%. Interventions Experimental: Rivaroxaban 20mg p.o., once daily, for six months Historical control: Phenprocoumon (Marcoumar) p.o., once daily Outcomes Primary outcome: Composite outcome of prosthetic thrombus requiring reoperation/intervention, major bleeding, visceral ischemia, stroke, pulmonary embolism, myocardial infarction or death from any cause 180 days after intervention. Secondary outcomes: Each component of the composite outcome plus serious adverse events. Prosthetic thrombus requiring reoperation/intervention plus non-clinically relevant thrombi will be used as an additional safety outcome. Molecular markers suitable for monitoring the effectiveness of rivaroxaban.
Vitamin K antagonists were hampered by several disadvantages, such as the need for frequent monitoring. In this context, new oral anticoagulants (NOACs) have been developed and are now available on the market. These NOACs, like all anticoagulant drugs, continue to be associated with an increased risk of bleeding. In addition, the lack of antidote and the absence of valid data regarding biological monitoring can pose problems in case of overdose or when emergency surgery is required. Studies investigating the pharmacokinetic properties of rivaroxaban and dabigatran, two NOACs now approved for the market, have shown high variability between individuals, with coefficients of variation of up to 60% for some pharmacokinetic parameters in patients treated after orthopaedic surgery. The relation between plasma concentrations of NOAC and bleeding risk has been clearly established in clinical trials. Dabigtran, rivaroxaban and apixaban are known substrates of P-glycoprotein (Pgp). Pgp activity can be affected by pharmacological inducing or inhibiting agents. This can lead to a significant change in the pharmacokinetics of NOACs, with a decrease or increase (respectively) in the level of intestinal absorption, leading to respectively reduced or increased plasma concentrations of the drug. Furthermore, there exist genetic mutations of Pgp, presenting in particular a lower level of activity than the non-mutated protein. We hypothesized that the polymorphisms (mutations) of the ABCB1 gene that codes for Pgp could influence plasma concentrations of dabigatran, rivaroxaban and apixaban, and consequently, impact on the concentration of NOACs and as a corollary, on the bleeding and thromboembolic risk of patients treated with these molecules. The main objective of this study is to study the relation between polymorphisms of the ABCB1 gene that codes for Pgp and plasma concentrations of NOACs in patients treated for a hemorrhagic or thromboembolic complication occurring under NOAC therapy. Secondary objectives are to evaluate the distribution of ABCB1 polymorphisms among the various hemorrhagic risk factors, and to compare the frequency of the polymorphism in patients from the study population vs the general population.
Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood clots (including strokes). Too much anticoagulation increases the risk of serious or even fatal bleeding, and too little anticoagulation fails to protect the patient against blood clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the therapeutic range, the range within which they are protected from clots but not at excessive risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following several relatively simple procedures, including following-up promptly when patients are out of range and focusing on educating and supporting patients with poor control. In this study, the investigators will promote these practices at the anticoagulation clinics of the New England VA region, with a goal of improving anticoagulation control.
The purpose of this study is to determine whether self-management of oral anticoagulation therapy with warfarin has an effect on patient's quality of life following a specific training program led by pharmacists.
Background: Heparin is an anticoagulant commonly used in the neonatal population as a means to prevent catheter related occlusion and malfunction by thrombosis (clot). Given the recent overdoses of infants using heparin, there is concern as to whether heparin should be used in peripherally inserted central venous catheters (PICC). Scientific evidence comparing the duration of use of heparin versus no heparin in PICCs is conflicting. Purpose: The purpose of this study is to evaluate the effect of continuous IV fluids with heparin versus IV fluids without heparin on the duration of percutaneously inserted central venous catheters (PICC) in neonates. Design: Prospective, double-blind, randomized controlled trial Hypothesis: The use of heparin in PICC fluids has no difference on duration of catheter patency. Design and Methods: The study will be conducted at the Neonatal Intensive Care Unit at University Hospital, San Antonio, TX. Randomization to either the experimental group (no-heparin) or the standard medical group (with heparin) will occur once parental consent is obtained and prior to PICC insertion. PICC placement will be done by the PICC certified neonatal nurses. Correct placement of the PICC will be assured by radiography which is standard procedure. Parents, NICU team members and staff, and investigators will be masked to the grouping. Pharmacy will be responsible for randomization. Both the heparin group and the no heparin group solutions will be dispensed in identical containers, compounded by the pharmacy. The study medication, heparin, will be mixed by the pharmacy at a standard dose of 0.5 units/mL for the intravenous infusions used in the heparin group. The experimental group will receive only the base solution, whether it is 5% dextrose, 0.9% sodium chloride, or total parenteral nutrition infused into the PICC line. Pharmacy and the NICU staff will ensure compatibility of heparin with other infusions. Heparin bonded catheters, heparin flushes, and hep-lock solutions are not used by the NICU service. The primary outcome, duration of catheter use, is defined as the time (in hours) between insertion and removal of the catheter due to occlusion. Occlusion will be defined as the inability to push 1 mL of 0.9% sodium chloride, via a 5 mL syringe, through the catheter in situ or detection of clots along the catheter after removal. Secondary outcomes include septicemia vs. catheter-related septicemia, phlebitis, death before discharge, and thrombosis. Septicemia is identified as clinical signs and symptoms associated with sepsis in the presence of a positive peripheral blood culture obtained irrespective of the catheter tip culture result. Catheter-related sepsis will be defined as positive blood culture obtained from the catheter fluid as well as a positive blood culture obtained from a peripheral venous specimen. Both cultures must demonstrate the same organism. Phlebitis is defined by visual detection, swelling, and change of skin color associated with an inflamed vein. Thrombosis is defined as a thrombus along catheter path diagnosed by visual inspection upon removal of the catheter. Elective versus non-elective removal will also be recorded. Adverse events monitored include: heparin induced thrombocytopenia (HIT), defined as a platelet count dropping below 50 x 103/mL with a positive antibody titer, aPTT > 100 seconds (This will be measured upon clinical evidence of bleeding), hemorrhage from > 2 sites, intraventricular hemorrhage, extravasation, and dislodgement or breakage of catheter. The sample size will be determined based on retrospective data collection to reach a statistical power of 80% with a type I error or 0.05. The investigators expect the sample size to be approximately 102 patients in each arm of the study. The study will terminate once the PICC is discontinued or if there is an indication to stop the study early for safety reasons. These could include increased adverse events in one group versus the other. A Safety Control Panel composed of 2 neonatologists from another site will review the data at the points when 1/3 and then 2/3 of total patient enrollment has been achieved. Data Collection and Analysis: Data will be collected and tabulated on a Microsoft Excel spreadsheet using unique patient identifiers and stored at a secure location at UHS then analyzed using appropriate statistical tests.
The study will assess the hypothesis that the combination warfarin & clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.
Deep vein thrombosis(DVT) is a common complication in hospitalized medical patients. Consensus guidelines recommend using medications such as heparin or low-molecular-weight heparins (LMWH) to prevent DVT in these patients. Generally, these medications are given in a fixed dose that is the same for everyone. The appropriate dose of medication in patients with severe obesity is uncertain. There is some evidence that the use of standard fixed-doses in severely obese patients may not provide adequate protection against DVT. The purpose of this study is to evaluate a weight-based dose(0.5 milligrams per kilogram of body weight) of the commonly prescribed LMWH, enoxaparin in severely obese patients to determine if predictable levels of blood thinning can be achieved. We hypothesize that dosing enoxaparin 0.5mg/kg once daily in severely obese patients will lead to predictable blood levels.
The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs.
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination