Effect of valproic acid on fibrinolysis in humans with atherosclerosis
- Conditions
- AtherosclerosisMedDRA version: 17.0Level: LLTClassification code 10003601Term: AtherosclerosisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-004950-27-SE
- Lead Sponsor
- Sahlgrenska universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method