In vitro potency of clinically used antiplatelet drugs in patients with Metabolic dysfunction Associated Fatty Liver Disease

Completed

Conditions: 10012653
10019654
Metabolic dysfunction Associated Fatty Liver Disease
Non-Alcoholic Steatohepatitis

Registration Number: NL-OMON51140

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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 (FibroScan F1-F4) with or without
diagnosis of diabetes mellitus

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

Exclusion Criteria

• Underlying liver disease with other aetiology than Metabolic dysfunction
Associated Fatty Liver Disease
• 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 invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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