Potency of Antiplatelet Drugs in MAFLD

Conditions: Metabolic dysfunction Associated Fatty Liver Disease

Registration Number: NL-OMON21913

Lead Sponsor: MCG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

Inclusion criteria study groups:
•= 18 years of age
•Signed informed consent
•Some degree of liver steatosis and fibrosis (F1-F4) with or without diagnosis of diabetes mellitus type 2

Inclusion criteria control group:
•= 18 years of age
•Signed informed consent

Exclusion Criteria

•Underlying liver disease with other aetiology than MAFLD
•Use of anti-platelet (salicylates, P2Y12 inhibitors, dipyridamole) or anti-hemostatic (heparins, vitamin K antagonists, direct oral anticoagulants) drugs
•Use of Non-Steroid Anti-Inflammatory Drugs 4 days prior to inclusion
•Documented history of hereditary thrombophilia or haemophilia
•Current malignancy
•Pregnancy
•Pre-existing immunosuppressive status (HIV positivity, previous solid organ transplant)
•Transfusion of blood products 7 days prior to inclusion
•Not willing to be notified of FibroScan results

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in platelet function after in vitro administration of active metabolites of antiplatelet drugs (aspirin, clopidogrel, ticagrelor) to the blood of patients with various stages of fibrosis due to MAFLD, compared to healthy controls. To estimate platelet function, we will assess platelet adhesion by Flow Based Adhesion, platelet activation by Flow Cytometry, and platelet aggregation by Whole Blood Aggregation.

Secondary Outcome Measures

Name	Time	Method
Baseline values, such as body weight, height, medical history, use of medications, use of alcohol, smoking status will be assessed. Parameters to define stage of steatosis and fibrosis due to MAFLD will be assessed with the use of a FibroScan (Controlled Attenuation Parameter Scores (dB/m) and FibroScan Fibrosis Score (kPa)). Other parameters involved in assessing the hemostatic status consist of markers for activation of platelets and coagulation (platelet factor 4, prothrombin fragment 1+2, thrombin-antithrombin complex), routine blood tests (platelet count, hemoglobin, von Willebrand factor, fibrinogen, prothrombin time, international normalized ratio, activated partial thromboplastin time).