Study of the Efficiency of Hydroxychloroquine on the Endothelial Dysfunction and Its Vascular Consequences During the Antiphospholipid Syndrome

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the benefits of hydroxychloroquine on arterial function in antiphospholipid syndrome.

Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine and standard treatment, the other will receive placebo in addition of standard treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Hydroxychloroquine

Criteria

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