Assessment of The Effect of Apixaban in AF

NCT03199521 | Completed DMC

• 3 other identifiers: No 1.1 Apr 2017CV185-622RD2017-03
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the effect of apixaban on thrombotic status in patients with atrial fibrillation.In addition it will compare apixaban to aspirin and warfarin on their effect on endogenous fibrinolysis.

Conditions

Atrial Fibrillation; Embolism Thrombosis

Keywords

apixaban; endogenous fibrinolysis; warfarin; aspirin; thrombotic status

Outcome Measures

Primary Outcomes (1)

• Assessing the effect of apixaban on endogenous fibrinolysis in patients wth atrial fibrillation

  Measuring endogenous fibrinolysis before and after apixaban

  Change of endogenous fibrinolysis from baseline at 4 weeks

Secondary Outcomes (1)

• Comparing the effect of apixaban to warfarin and aspirin on endogenous fibrinolysis in patients with atrial fibrillation

  12 months

Study Arms (3)

Atrial Fibrillation newly diagnosed, starting apixaban

Patients will undergo the global thrombosis test (GTT), thromboelastography (TEG) and thrombin generation assays before and after stabilisation(4 weeks) of their anticoagulation. This will allow to compare the effect of apixaban on endogenous fibrinolysis before and after treatment.

Other: Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)

Atrial fibrillation on stable warfarin treatment

Patients will undergo the global thrombosis test (GTT), thromboelastography (TEG) and thrombin generation assays on stable anticoagulation treatment. This will allow to compare the effect of apixaban against warfarin on endogenous fibrinolysis on stable treatment.

Other: Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)

Atrial Fibrillation on stable aspirin treatment

Patients will undergo the global thrombosis test (GTT), thromboelastography (TEG) and thrombin generation assays on stable anticoagulation treatment. This will allow to compare the effect of apixaban against aspirin on endogenous fibrinolysis on stable treatment.

Other: Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)

Interventions

Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT) OTHER

Global Thrombosis Test (GTT): assesses formation of the blood clot and how easily can this be broken down once formed) Thromboelastography (TEG) :assesses the properties of a blood clot and how easily can be broken down Thrombin generation assays: assesses the formation of a blood clot and the potential of thrombolysis via the introduction of different buffer solutions

Atrial Fibrillation newly diagnosed, starting apixaban; Atrial Fibrillation on stable aspirin treatment; Atrial fibrillation on stable warfarin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-valvular atrial fibrillation. Participants will be recruited via inpatient and outpatient clinical areas.

You may qualify if:

• Age \>18 years
• Diagnosis of NVAF (nonvalvular atrial fibrillation)
• Requiring anticoagulation or antiplatelet therapy for thromboprophylaxis of stroke and systemic embolism

You may not qualify if:

• Patient unwilling or unable to give informed consent
• Patient who, in the opinion of the investigator, has significant hepatic or renal impairment likely to cause a bleeding diathesis
• Patient needing systemic high dose steroids or immunosuppression that may impact on platelet function
• Patient with ongoing active alcohol or substance abuse or demonstrates signs or clinical features of active substance abuse
• Patient with any major bleeding diathesis or blood dyscrasia at baseline (platelets\<70 x 109/l, Hb\<80 g/l, INR \>1.4 (international normalized ratio), APTT (activated partial thromboplastin time ) \> x 2UNL (upper normal limit) , leucocyte count\< 3.5x 109/l, neutrophil count\<1x 109/l).
• Patient currently involved in another investigational trial of a medicine or medical device

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• University of Hertfordshire: collaborator

Study Sites (1)

Hertfordshire Cardiology Centre, East and North Hertfordshire NHS Trust

Stevenage, SG14AB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Atrial Fibrillation; Embolism and Thrombosis

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,University of Hertfordshire

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 27, 2017
• Study Start: June 1, 2017
• Primary Completion: January 2, 2019
• Study Completion: January 2, 2019
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)