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

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ClinicalTrials.gov Identifier: NCT02218476
Recruitment Status : Unknown
Verified August 2014 by Maimónides Biomedical Research Institute of Córdoba.
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coenzyme Q10 on Athero-thrombosis in APS Patients Drug: CoQ10 Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2013
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
APS Patient Drug: CoQ10
Drug: Placebo



Primary Outcome Measures :
  1. Change in endothelial function in vivo [ Time Frame: 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 :
  1. Change in Tissue factor [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218476


Contacts
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Contact: Maria de los Angeles Aguirre, Medicine 0034639410897 maaguirrezamorano@yahoo.es

Locations
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Spain
Hospital Universitario Reina Sofía de Córdoba Recruiting
Cordoba, Andalucía, Spain, 14004
Contact: Aguirre         
Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
Investigators
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Principal Investigator: Rosario Lopez Pedrera, Biology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT02218476    
Other Study ID Numbers: PI12-01511
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Coenzyme Q10
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs