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

NCT02448901 | Unknown

• 1 other identifier: 2213
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Assessment of clot physiology of a blood sample in the presence and absence of edoxaban by point of care thrombelastography (TEG-6s)

  1 year

Interventions

Edoxaban DRUG

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

Also known as: DU-176b, trade names Savaysa, Lixiana

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers (n=20) Heart Failure Patients (n=20)

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.

Sponsors & Collaborators

• LifeBridge Health: lead
• Daiichi Sankyo: collaborator

Study Sites (1)

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• paul gurbel, MD

  Sinai Center for Thrombosis Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin P Bliden, BS, MBA

CONTACT

410-601-4795; kbliden@lifebridgehealth.org

Udaya Tantry, PhD

CONTACT

410-601-4795; utantry@lifebridgehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sinai Center for Thrombosis Research

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 20, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 20, 2015

Record last verified: 2015-05

Locations

US (1)