Influence of Edoxaban on Coagulability and Thrombin Generation: An in Vitro Study Focusing on Thrombelastography

Status unconfirmed

Conditions studied: Heart Failure

In brief

The influence of different doses of edoxaban on physical characteristics of the clot and thrombin generation kinetics in blood samples will be studied by in vitro spiking of blood samples collected from patients treated for heart failure (with and without hypercoagulability) and from healthy volunteers (with and without hypercoagulability). This in vitro experiment will help us to: (i) detect qualitative anticlotting properties of edoxaban. (ii) quantify the anticlotting properties of edoxaban.

Key facts

Study ID

NCT02448901

Run by

LifeBridge Health

People needed

40

Starts

2015-04-01

Expected to finish

2016-03-01

Last updated by the study team

2015-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with heart failure (class I-IV) are eligible for enrollment:
• Patient must have documented symptomatic chronic HF for at least 3 months prior to screening. Exacerbation of chronic HF is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization HF medications.
• Subject must have a documented LVEF of less than or equal to 40% within 3 months of the study. If more than one LVEF is available, the most recent one should be used, but it must be less than or equal to 40%. The ejection fraction will be determined by one of the following methods: echocardiogram, nuclear multigated acquisition (MUGA) scan, cardiac MRI, cardiac CT scan, or left ventriculography.
• Patient must be receiving appropriate HF treatment at the appropriate dosing per guidelines:
• Diuretic (required for study entry) Renin-angiotensin system (RAS) inhibitors such as an ACE inhibitor, or ARB if intolerant of ACE inhibitor, or vasodilator therapy such as hydralazine or nitrates if intolerant to ACE inhibitor and ARB
• Beta blocker therapy
• Aldosterone antagonist therapy.
• Patient must have completed all prophylactic anticoagulation (such as enoxaparin, warfarin, heparin, etc) for at least one week before study.
• Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and is willing to participate in the study.

You may not qualify if…

• For Healthy Subjects:
• subjects currently on antiplatelet therapy or any other agents that are known to influence platelet function and coagulation.
• For Subjects with Heart Failure:
• Hemodynamic instability, active bleeding and bleeding diatheses, oral anticoagulation therapy, leukocyte count < 3,000/mm3, platelet count < 100,000/mm3, aspartate aminotransferase or alanine aminotransferase levels ≥ 3 times upper normal, and creatinine >2mg/dL.
• Patient has a severe concomitant disease such as: Atrial fibrillation (AFib) or another condition that requires chronic anticoagulation.

Where it is running

• Sinai Center for Thrombosis Research — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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