Coenzyme Q10 on Athero-thrombosis in APS Patientscoenzyme Q10NCT02218476
Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients
A study testing CoQ10 in people with Coenzyme Q10 on Athero-thrombosis in APS Patients, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coenzyme Q10 on Athero-thrombosis in APS Patients
- What is being tested?
- CoQ10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute Liver Disease.
- Severe renal impairment
- Acute arterial or venous thrombosis episode in the last 3 months
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Reina Sofía de Córdoba
Córdoba, Andalusia, 14004
Aguirre
About this study
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.
- Being tested
- CoQ10, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| APS Patient | Other | Not described Receives: Drug: CoQ10; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 weeks, 4 weeks, 8weeks, 12weeks
Secondary outcomes (1)
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.
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coenzyme Q10 on Athero-thrombosis in APS PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosario Lopez Pedrera, Biology, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218476
- Sponsor's protocol ID
- PI12-01511
- Acronym
- coenzyme Q10
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
Publications
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.
PubMed 28684614
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients
- ClinicalTrials.gov ID
- NCT02218476
- Acronym / sponsor ID
- coenzyme Q10 / PI12-01511
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (estimated)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APS Patient | Other | Drug: CoQ10, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Acute Liver Disease.
- Severe renal impairment
- Acute arterial or venous thrombosis episode in the last 3 months
- Pregnancy and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10 | Drug | APS Patient |
| Placebo | Drug | APS Patient |
Primary outcome
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.
1 secondary outcome
Change in Tissue factor
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Derived from this study: PubMed 28684614Perez-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosario Lopez Pedrera, Biology principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoQ10 in people with Coenzyme Q10 on Athero-thrombosis in APS Patients, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria de los Angeles Aguirre, Medicine (0034639410897, maaguirrezamorano@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial function in vivo (time frame: 0 weeks, 4 weeks, 8weeks, 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02218476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.