NCT01781611

Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE)

Dipyridamole Assessment for Flare Reduction in SLE

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Oklahoma Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Dipyridamole, a medication extensively used in combination with aspirin for stroke prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of lupus-related pathology in mice with lupus. The investigators are interested in investigating the efficacy of dipyridamole in preventing flares in patients with lupus and its impact on biomarkers of disease activity.

Detailed description

T cells in systemic lupus erythematosus (SLE) express an abnormal phenotype characterized by increased effector functions and deficient regulatory responses. Dipyridamole, a phosphodiesterase inhibitor extensively used in combination with low dose aspirin in secondary stroke prevention, has been proposed as a specific T cell directed treatment for SLE. Dipyridamole inhibits the calcium/calcineurin/NF-AT pathway in SLE T cells in vitro and abrogates expression of cytokines and costimulatory molecules, eventually also affecting B cell responses. Dipyridamole delays the emergence of lupus related pathology in lupus prone mice, but has not yet been studied in humans with SLE. The investigators aim to investigate the efficacy of dipyridamole in the prevention of flares in SLE patients after withdrawal of background immunosuppressive medications. The investigators will additionally evaluate the safety and tolerability of dipyridamole and its impact on quality of life measures in this population. Furthermore, the effect of dipyridamole on T and B cell biomarkers will be examined.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	extended release dipyridamole 200mg/aspirin 25mg	one tablet twice daily for 24 weeks
DRUG	81mg aspirin	half a tablet twice daily for 24 weeks

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-05-01
• Completion: 2017-11-01
• First posted: 2013-02-01
• Last updated: 2020-11-25
• Results posted: 2020-11-25

Locations

1 site across 1 country: United States