The fibrinolytic system MedDRA version: 18.0 Level: LLT Classification code 10016611 Term: Fibrinolytic activity increased System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Ergenyl Retard
Product Name: Ergenyl Retard 500 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: VALPROIC ACID
CAS Number: 99-66-1
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Sahlgrenska Akademien Wallenberglaboratoriet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For all subjects: 1.Subect has given informed consent 2.Men and women aged 20 -85 years 3.Non smoker Additional for patients with coronary artery disease: 4.Pronounced atherosclerosis 5.Treatment for acute myocardial infarction for more than a year ago 6.Only Trombyl (no other anticoagulant therapy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1.Smoking 2.BMI (body mass index) >35 kg / m² 3.Epilepsy 4.Uncontrolled hypertension 5.Malignancy 6.Mental disorder 7.Alcoholism 8.All forms of chronic illness with medications that are contraindicated to combine with Ergenyl 9.Acute infection 10.Difficulties in implementing the study with regard to the inability to lie still on a gurney because of the general condition or obvious difficulty with putting vein / artery catheter 11.Interaction with Ergenyl 12.Known hypersensitivity to valproic acid or other component included 13.Ongoing or planned pregnancy within the next 3 months 14.Breastfeeding women 15.Suspected or actual inability to perceive the study of information and instruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary purpose of this study is to examine the mechanisms with VPAs down-regulating effect on PAI-1 in humans;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the analysis of PAI-1 during VPA treatment;Timepoint(s) of evaluation of this end point: Blood samples will be drawn at 08, 12 and 17 at each visit for the analysis of study parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Fibrinolysfaktorer (PAI-1, t-PA, u-PA, D-dimer, fibrinogen etc.), blood flow, blood pressure, heart rate and lactate levels will be analyzed;Timepoint(s) of evaluation of this end point: Blood samples will be drawn at 08, 12 and 17 at each visit for the analysis of study parameters | — |
Countries
Sweden
Contacts
Public ContactWallenberglaboratoriet
Sahlgrenska Akademien
Outcome results
None listed