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Anticoagulants clinical trials

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NCT ID: NCT02777047 Completed - Anticoagulants Clinical Trials

Coordination of Oral Anticoagulant Care at Hospital Discharge

COACHeD
Start date: December 16, 2020
Phase: N/A
Study type: Interventional

Oral anticoagulants (OACs - warfarin, dabigatran, rivaroxaban, apixaban and edoxaban) are the very top cause of serious drug-related harm. More than 7 million prescriptions are dispensed annually for oral anticoagulants (OAC) in Canada, with more than 340,000 elderly recipients in the Ontario Drug Benefit Program alone. Because of their very high and chronic utilization, their large benefit in lowering important clinical events (stroke, clots, death) and their high potential for major harm (primarily bleeds, which can be fatal), OACs are the highest priority for improving medication safe and effective use. The early period after hospital discharge is clearly high risk, with three times the usual rate of major bleeds compared with later. Patients and families frequently note confusion about their medications after leaving the hospital due to errors or lack of detailed communication to their health care team at the time of discharge. The confusion, errors, and lack of communication are highly associated with lack of adherence to medications and resulting worse health outcomes. The combination of waste of medication and bad outcomes that result from medication errors, are estimated to cost our health care system several billion dollars annually. Since our leading economists are declaring health care to be unsustainable in its current delivery forms, it is time to find and evaluate more cost-effective ways to improve anticoagulation safety. The investigators will do this by structuring discharge medication assessment, with more expert management, formal written and verbal handovers to the patients, their family and their hospital and community doctors, pharmacists and home care; follow-up by virtual visits after discharge, and coordinate advice and communication to extend access to and reduce the cost of expert guidance. The investigators expect that this intervention will decrease anticoagulant-related adverse events and improve ratings of the coordination of care. If this occurs, the investigators will develop a business plan for regions, provinces and territories to scale up the intervention to a national level.

NCT ID: NCT02360943 Completed - Pulmonary Embolism Clinical Trials

Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: PEAGE

PEAGE
Start date: July 9, 2014
Phase:
Study type: Observational

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.

NCT ID: NCT02103101 Completed - Hemorrhage Clinical Trials

Influence of ABCB1 Polymorphisms on Plasma Concentrations of New Oral Anticoagulants in Case of Serious Adverse Events

Pgp NACO
Start date: November 13, 2014
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01653405 Completed - Atrial Fibrillation Clinical Trials

Improving Anticoagulation Control in VISN 1

Start date: October 1, 2014
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT01033279 Completed - Quality of Life Clinical Trials

Quality of Life and Efficacy Evaluation of Patient Self-monitoring Their Oral Anticoagulation Therapy

ESCAPE
Start date: October 2009
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00769938 Completed - Atrial Fibrillation Clinical Trials

WOEST ( What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing)

WOEST
Start date: December 2008
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00585182 Completed - Obesity Clinical Trials

Study to Evaluate Weight-based Enoxaparin Dosing in Obese Medical Patients at Risk for DVT

Start date: January 2007
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00287313 Completed - Anticoagulants Clinical Trials

Daily Vitamin K in Patients on Warfarin With Unstable INRs

Start date: October 2005
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00222638 Completed - Anticoagulants Clinical Trials

Influenza Vaccination and Oral Anticoagulant Therapy

Start date: October 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination