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

Not Applicable

• Conditions: Coenzyme Q10 on Athero-thrombosis in APS Patients
• Interventions: Drug: CoQ10; Drug: Placebo

• Registration Number: NCT02218476
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-08
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-14
• Last Update Submitted: 2014-08-14
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
APS Patient	CoQ10	-
APS Patient	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in endothelial function in vivo	0 weeks, 4 weeks, 8weeks, 12weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Tissue factor	0 weeks, 4 weeks, 8 weeks, 12 weeks	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.

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía de Córdoba; 🇪🇸 Cordoba, Andalucía, Spain