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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)

Primary Purpose

Coenzyme Q10 on Athero-thrombosis in APS Patients

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CoQ10
Placebo
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coenzyme Q10 on Athero-thrombosis in APS Patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Reina Sofía de CórdobaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

APS Patient

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2014
Last Updated
August 14, 2014
Sponsor
Maimónides Biomedical Research Institute of Córdoba
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1. Study Identification

Unique Protocol Identification Number
NCT02218476
Brief Title
Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients
Acronym
coenzyme Q10
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coenzyme Q10 on Athero-thrombosis in APS Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Arm Title
APS Patient
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
CoQ10
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in endothelial function in vivo
Description
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.
Time Frame
0 weeks, 4 weeks, 8weeks, 12weeks
Secondary Outcome Measure Information:
Title
Change in Tissue factor
Description
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.
Time Frame
0 weeks, 4 weeks, 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome) (Miyakis S et al., J Thromb Haemost 2006; 4:295-306) Age over 18 years Written informed consent Exclusion Criteria: Acute Liver Disease. Severe renal impairment Acute arterial or venous thrombosis episode in the last 3 months Pregnancy and breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria de los Angeles Aguirre, Medicine
Phone
0034639410897
Email
maaguirrezamorano@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario Lopez Pedrera, Biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía de Córdoba
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aguirre

12. IPD Sharing Statement

Citations:
PubMed Identifier
28684614
Citation
Perez-Sanchez C, Aguirre MA, Ruiz-Limon P, Abalos-Aguilera MC, Jimenez-Gomez Y, Arias-de la Rosa I, Rodriguez-Ariza A, Fernandez-Del Rio L, Gonzalez-Reyes JA, Segui P, Collantes-Estevez E, Barbarroja N, Velasco F, Sciascia S, Cecchi I, Cuadrado MJ, Villalba JM, Lopez-Pedrera C. Ubiquinol Effects on Antiphospholipid Syndrome Prothrombotic Profile: A Randomized, Placebo-Controlled Trial. Arterioscler Thromb Vasc Biol. 2017 Oct;37(10):1923-1932. doi: 10.1161/ATVBAHA.117.309225. Epub 2017 Jul 6.
Results Reference
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Learn more about this trial

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

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