Coenzyme Q10 on Athero-thrombosis in APS Patients Clinical Trial
— coenzyme Q10| NCT number | NCT02218476 |
| Other study ID # | PI12-01511 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | August 8, 2014 |
| Last updated | August 14, 2014 |
| Start date | September 2013 |
The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes operated on various prothrombotic/proinflammatory parameters and their associated intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity; mitochondrial antioxidant system characterization; Expression levels and activity of transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2), Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs microarrays, RT-PCR validation and correlation/association studies. 6) Induction of over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome) (Miyakis S et al., J Thromb Haemost 2006; 4:295-306) 2. Age over 18 years 3. Written informed consent Exclusion Criteria: 1. Acute Liver Disease. 2. Severe renal impairment 3. Acute arterial or venous thrombosis episode in the last 3 months 4. Pregnancy and breastfeeding |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Reina Sofía de Córdoba | Cordoba | Andalucía |
| Lead Sponsor | Collaborator |
|---|---|
| Maimónides Biomedical Research Institute of Córdoba |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in endothelial function in vivo | Study of the endothelial function in vivo. Variations in capilar blood flow of the skin will be analyzed by noninvasive Doppler laser fluorimetry using a Periflux 5000 equipment. The study will be performed on 50 APS (antiphospholipid Syndrome) patients. Patients will be randomized to CoQ10 or placebo group. Treatments will be given for 1 month, according to a randomized and crossover design (with wash-out periods of four weeks) Blood will be drawn at time 0, at the end of treatment, and after three months of the end of treatment. |
0 weeks, 4 weeks, 8weeks, 12weeks | No |
| Secondary | Change in Tissue factor | Parameters related to inflammation and thrombosis in cells measure at mRNA and VEGF (Vascular Endothelial Growth Factor) in serum/plasma and cells. The study will be performed on 50 APS (antiphospholipid Syndrome) patients. Patients will be randomized to CoQ10 or placebo group. Treatments will be given for 1 month, according to a randomized and crossover design (with wash-out periods of four weeks) Blood will be drawn at time 0, at the end of treatment, and after three months of the end of treatment. |
0 weeks, 4 weeks, 8 weeks, 12 weeks | No |