Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients (coenzyme Q10)

Maimónides Biomedical Research Institute of Córdoba

Status: Unknown

Conditions: Coenzyme Q10 on Athero-thrombosis in APS Patients

Treatments: Drug: CoQ10; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02218476

PI12-01511

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 1 patient group

APS Patient

Other group

Treatment:

Drug: CoQ10

Drug: Placebo