How valproic acid affects the body's own ability to dissolve blood clots
- Conditions
- The fibrinolytic systemMedDRA version: 18.0Level: LLTClassification code 10016611Term: Fibrinolytic activity increasedSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-001092-49-SE
- Lead Sponsor
- Sahlgrenska Akademien Wallenberglaboratoriet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
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