Atherosclerosis MedDRA version: 17.0 Level: LLT Classification code 10003601 Term: Atherosclerosis System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Ergenyl Retard
Product Name: Ergenyl Retard
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: VALPROIC ACID
CAS Number: 99-66-1
Other descriptive name: Ergenyl Retard
Con
Sponsors
Sahlgrenska universitetssjukhuset
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Given informed consent 2. Men and women aged 50 -85 years 3. Treated for acute myocardial infarction for = 1 year ago 4. Severe artherosclerosis (3-vessel disease, syntax score > 20) 5. Non-Smoker 6. No other anticoagulants except Trombyl 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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. Any form of chronic disease contraindicated to combine with Ergenyl 9. Acute infection 10.Inability to stay in a hospital bed because of general condition or due to obvious difficulties with putting vein/artery catheter 11.Interaction between Ergenyl and the patient's medications 12.Known hypersensitivity to valproic acid or any components contained 13.Inability to understand study information and/or instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine whether upregulation of tPA production by valproic acid results in increased tPA release from the endothelium in humans;Secondary Objective: No;Primary end point(s): tPA release. Blood flow, blood pressure, heart rate, lactate levels and fibrinolysis fakcors will also be measured;Timepoint(s) of evaluation of this end point: 4 weeks after Valpolic acid treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No | — |
Countries
Sweden
Contacts
Public ContactKristina Svennerholm
Sahlgrenska universitetssjukhuset
Outcome results
None listed