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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02595346 |
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Date of registration:
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02/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of the Efficiency of Hydroxychloroquine on the Endothelial Dysfunction and Its Vascular Consequences During the Antiphospholipid Syndrome
APLAQUINE |
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Scientific title:
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Efficiency of Hydroxychloroquine on the Endothelial Dysfunction in Antiphospholipid Syndrome (APLAQUINE) |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02595346 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Sébastien MIRANDA, MD |
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Address:
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Telephone:
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Email:
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sebastien.miranda@chu-rouen.fr |
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Affiliation:
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Name:
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Sébastien MIRANDA, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rouen University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome
- Women of childbearing potential must have a contraceptive method
- Written informed consent
- no severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart,
or brain disease.
Exclusion Criteria:
- secondary antiphospholipid syndrome
- Pregnancy and breastfeeding
- Patients with a history of severe depression, psychosis, or suicidal ideation
- story of intolerance or contra-indication to hydroxychloroquine, lactose, trinitrin
- Prior use of hydroxychloroquine in the last 6 months
- Chronic heart failure
- atrial fibrillation
- severe pulmonary hypertension
- severe kidney failure clearance < 30ml/mn
- uncontrolled arterial hypertension
- secondary arterial hypertension
- diabetes mellitus diagnosed in the last 3 months
- body mass index > 35
- Patient has been committed to an institution by legal or regulatory order
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Antiphospholipid Syndrome (APS)
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Intervention(s)
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Drug: Hydroxychloroquine
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Drug: placebo
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Primary Outcome(s)
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Change from baseline flow mediated dilatation of brachial artery
[Time Frame: 6 months]
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Secondary Outcome(s)
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change from baseline in oxydative stress
[Time Frame: 6 months]
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change from baseline in endothelial glycocalyx thickness
[Time Frame: 6 months]
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change from baseline in plasmatic level in hydroxychloroquine
[Time Frame: 6 months]
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change from baseline in systemic inflammation
[Time Frame: 6 months]
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change from baseline in coagulation parameter
[Time Frame: 6 months]
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Secondary ID(s)
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2015/074/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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