Recruiting

Edoxaban

Sponsor:

LifeBridge Health

Code:

NCT02448901

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Edoxaban

Study Details

Brief summary:

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.

Conditions

Heart Failure

Study ID

NCT02448901

Start date

Apr, 2015

Status verified date

May, 2015

Completion date

Mar, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patients with heart failure (class I-IV) are eligible for enrollment:

1. 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.
2. 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.
3. 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.
4. Patient must have completed all prophylactic anticoagulation (such as enoxaparin, warfarin, heparin, etc) for at least one week before study.
5. 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.

Exclusion Criteria:

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:

1. 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.
2. Patient has a severe concomitant disease such as: Atrial fibrillation (AFib) or another condition that requires chronic anticoagulation.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Edoxaban

In vitro study. Various concentrations of Edoxoban added to blood sample and tested

Primary outcome measure

  • Assessment of clot physiology of a blood sample in the presence and absence of edoxaban by point of care thrombelastography (TEG-6s) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Sinai Center for Thrombosis Research

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

More Information

Sponsor

LifeBridge Health

Last update posted

May 20, 2015

Last verified

May, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2015-05-20.