Patients must meet the classification criteria for arterial antiphospholipids syndrom. They must have had a confirmed episode of arterial thrombosis and the presence of 2 tests performed at 12 weeks apart of anti-cardiolipin (IgG or IgM ),and anti-B2GP1 (IgG or IgM ), or circulating anticoagulants. MedDRA version: 18.0 Level: PT Classification code 10002817 Term: Antiphospholipid syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Plaquenil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
CAS Number: 747-36-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
CHU - Hôpitaux de Rouen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients > 18 years old -Patients must meet the classification criteria for arterial antiphospholipid syndrom. They must have had a confirmed episode of arterial thrombosis and the presence of 2 tests performed at 12 weeks apart of anti-cardiolipin (IgG or IgM ),and anti-B2GP1 (IgG or IgM ), or circulating anticoagulants. -Patients must be clinically stable (NB : all of stages severity disease will be accepted) -Patients with medical insurance -Having read and understood the information letter and signed the consent form -For women of childbearing age, they needs to take a effective contraception since 1 month (progestin or intrauterin device or tubal ligation) with a negative pregnancy test. (NB: Will be considered postmenopausal women with amenorrhea for more than 2 years) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Treatment with hydroxychloroquine (Plaquenil®) already established or stopped for less than 3 months -Contraindications to Plaquenil® (retinopathy) and sensitivity to chloroquine or hydroxychloroquine or any of the other constituents of Plaquenil® -Patients presenting a non-arterial or secondary antiphospholipid syndrome -Symptomatic atherosclerotic disease: Myocardial infarction, angina, coronary revascularization, stroke or transient constituted, arteritis obliterans of lower limbs. -Heart failure and / or significant valvulopathy. -Secondary arterial hypertension. -Severe hypertension (DBP = 110 mm Hg and / or SBP = 180 mm Hg) -Atrial fibrillation. -BMI > 35 kg / m2. -Diabetes diagnosed since more than 3 months. -Severe chronic renal impairment (creatinine clearance <30 ml / min according to the Cockroft formula). -Patients with ophthalmic conditions defined by ophthalmologists which oppose the treatment by hydroxychloroquine -Introduction of any treatment with platelet aggregation inhibitor or anti-inflammatory non-steroid within 7 days preceding the study -Allergy to lactose - Contraindications to trinitrine -Pregnant or breastfeeding women or absence of contraception used -Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection (guardianship, trusteeship) - Patients participating in another trial or participated in another trial during the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the effect of Plaquenil® on endothelial function, comparatively to a control group, in a population of patient suffering of primary arterial antiphospholipid syndrome;Secondary Objective: 1. Evaluating the effect of Plaquenil® on endothelial glycocalyx 2. Evaluating the effect of Plaquenil® on the inflammatory profile 3. Evaluating the effect of Plaquenil® on the oxydative stress level 4. Evaluating the effect of Plaquenil® on the via tissue factor 5. HCQ assay ;Primary end point(s): Measuring the variation of the endothelium-dependent dilatation of the brachial artery between baseline and after 6 months of treatment;Timepoint(s) of evaluation of this end point: - inclusion day , 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Measuring the thickness of the endothelial glycocalyx Assays soluble compounds of the glycocalyx Evaluation of oxidative stress Evaluation of the inflammatory component Determination of plasma tissue factor Assay of hydroxychloroquine ;Timepoint(s) of evaluation of this end point: - inclusion day 3 and 6 months | — |
Countries
France
Contacts
Public ContactFlorence GRELLET
CHU - Hôpitaux de Rouen
Outcome results
None listed