Hydroxychloroquine for Thrombosis Prevention and Antiphospholipid Antibody Reduction in Primary Antiphospholipid Syndrome

NCT04153201 | Completed

• 1 other identifier: SC668/10062016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional drug study designed as a pilot for a randomized clinical trial, aimed at assessing the effect of hydroxychloroquine on the incidence rate of thrombosis in patients with primary antiphospholipid syndrome as the main outcome, as well as the safety of hydroxychloroquine administration in this population. In addition, the effect of hydroxychloroquine on antiphospholipid antibody titers will be assessed.

Conditions

Antiphospholipid Syndrome

Keywords

antiphospholipid antibody titers; thrombosis prevention; hydroxychloroquine; antimalarials; antiphospholipid syndrome

Outcome Measures

Primary Outcomes (1)

• Incident acute thrombosis in the venous or arterial circulation

  incident acute arterial thrombosis (myocardial infarction, stroke, transient ischemic attack, occlusion of the peripheral limb and neck, splanchnic, or retinal arteries) or venous thrombosis (pulmonary embolism, deep vein thrombosis, splanchnic vein thrombosis, retinal vein occlusion) confirmed by appropriate imaging studies (doppler ultrasonography, computed tomography pulmonary angiogram, conventional angiography, magnetic resonance angiography, ventilation/perfusion lung scintigraphy)

  3 years

Secondary Outcomes (3)

• Hydroxychloroquine-related safety outcomes

  3 years

• Anticoagulation treatment-related safety outcomes

  3 years

• General safety outcomes

  3 years

Other Outcomes (1)

• Antiphospholipid antibody titer variation

  3 years

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Patients with primary antiphospholipid syndrome started on hydroxychloroquine while continuing standard care (vitamin K antagonists or direct oral anticoagulants, and/or antiplatelet agents, depending on primary APS subgroup)

Drug: Hydroxychloroquine

Standard care

NO INTERVENTION

Patients with primary antiphospholipid syndrome continuing standard care only (vitamin K antagonists or direct oral anticoagulants, and/or antiplatelet agents

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 200 mg daily for patients weighing \< 60 kg, hydroxychloroquine 400 mg daily for patients weighing \>= 60 kg

Also known as: Antimalarials, Plaquenil

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients diagnosed with primary antiphospholipid syndrome (PAPS) \[updated Sapporo criteria: Miyakis et al, J Thromb Haemost. 2006 Feb;4(2):295-306. PubMed 16420554\]

You may not qualify if:

• ≥4 American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)
• ACR classification criteria for other systemic autoimmune disorders
• active malignancy
• treatment with Hydroxychloroquine (HCQ) in the previous 12 months
• history of serious adverse events or contraindication to HCQ including a history of HCQ allergy, HCQ eye toxicity, or glucose-6-phosphate dehydrogenase deficiency, uncontrolled seizure disorder, liver enzyme elevation \>2-fold the upper normal limit, and creatinine clearance \<30ml/min

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Laikon General Hospital

Athens, Attica, 11527, Greece

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Hydroxychloroquine; Antimalarials

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Maria G Tektonidou, MD PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Rheumatology

Model Details: 1 intervention arm (Hydroxychloroquine plus standard care), 1 control arm (standard care) Patients randomized 1:1 using block size 2 randomization

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: November 6, 2019
• Study Start: January 15, 2013
• Primary Completion: October 1, 2019
• Study Completion: October 16, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data will become available 6 months following publication of results, and will remain accessible for 2 years
• Access Criteria: Individual patient data will be provided to researchers in order to perform relevant meta-analyses, after review and approval of the meta-analysis protocol. Potential publications of our results with the same data should be cited if sharing our data results in new publications.

Locations

GR (1)