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

• Status: Terminated
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oklahoma Medical Research Foundation
• Treatments: Aspirin; Dipyridamole

Criteria

Inclusion Criteria:

• Patients with SLE meeting the 1997 ACR Classification Criteria

• Evidence of positive ANA or anti-dsDNA within one year of screening

• SLEDAI ≥4 or ≥1 BILAG A or B at screening, despite standard of care

Exclusion Criteria:

• Leukopenia (WBC <2.000/mm3) or lymphopenia (lymphocytes < 300/mm3)

• AST or ALT >3 times above normal cut off values

• Acute lupus nephritis defined as class II, IV or V nephritis diagnosed within 6 months or prot/creat > 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis

• Active CNS lupus affecting mental status

• Pregnancy or breast feeding

• Current requirement for anticoagulation

• Contraindication to aspirin or dipyridamole, including history of recent or severe GI bleeding, hemoglobin <9 mg/dL, platelet count of <30,000 /mm3 or unstable platelet count

• Any other medical condition, whether or not related to lupus which, in the opinion of the investigator would render the patient inappropriate or too unstable to complete the study protocol

• Inability or unwillingness to understand and/or sign informed consent