NCT02218476

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

3 years

First QC Date

August 8, 2014

Last Update Submit

August 14, 2014

Conditions

Coenzyme Q10 on Athero-thrombosis in APS Patients

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in Tissue factor

    0 weeks, 4 weeks, 8 weeks, 12 weeks

Study Arms (1)

APS Patient

OTHER
Drug: CoQ10Drug: Placebo

Interventions

CoQ10DRUG
APS Patient
PlaceboDRUG
APS Patient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute Liver Disease.
  • Severe renal impairment
  • Acute arterial or venous thrombosis episode in the last 3 months
  • Pregnancy and breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Reina Sofía de Córdoba

Córdoba, Andalusia, 14004, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28684614DERIVED

MeSH Terms

Interventions

coenzyme Q10

Study Officials

  • Rosario Lopez Pedrera, Biology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria de los Angeles Aguirre, Medicine

CONTACT

0034639410897maaguirrezamorano@yahoo.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 18, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2016

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

ES(1)