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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01781611
Recruitment Status : Recruiting
First Posted : February 1, 2013
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: extended release dipyridamole 200mg/aspirin 25mg Drug: 81mg aspirin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dipyridamole Assessment for Flare Reduction in SLE
Study Start Date : February 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: extended release dipyridamole/aspirin
extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks
Drug: extended release dipyridamole 200mg/aspirin 25mg
one tablet twice daily for 24 weeks
Other Name: Aggrenox

Active Comparator: aspirin
half a tablet of a 81mg aspirin twice daily for 24 weeks
Drug: 81mg aspirin
half a tablet twice daily for 24 weeks

Primary Outcome Measures :
  1. British Isles Lupus Assessment Group Responder Index (BICLA) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Time to first flare [ Time Frame: 24 weeks ]
  2. Systemic Responder Index (SRI) 4/5 [ Time Frame: 24 weeks ]
  3. Health related quality of life [Lupus Quality of Life (Lupus QoL), Short Form 36v2] [ Time Frame: 24 weeks ]
  4. Fatigue (FACIT-fatigue score) [ Time Frame: 24 weeks ]
  5. Sleep quality [Pittsburgh Sleep Quality Index (PSQI)] [ Time Frame: 24 weeks ]
  6. Depression [Center for Epidemiologic Studies Depression (CES-D) Scale] [ Time Frame: 24 weeks ]
  7. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]
  8. SRI component analyses [ Time Frame: 24 weeks ]
  9. Cutaneous Lupus Disease Area and Severity Index (CLASI) [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. serum immunoglobulins [ Time Frame: 24 weeks ]
  2. serum cytokines [ Time Frame: 24 weeks ]
  3. T and B cell immunophenotyping [ Time Frame: 24 weeks ]
  4. T cell biomarkers after in vitro T cell stimulation [ Time Frame: 24 weeks ]
  5. T and B cell gene expression profiling [ Time Frame: 24 weeks ]
  6. Heart rate variability [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 lymhopenia (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781611

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Contact: Katherine Thanou, MD 405-271-7805

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United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Oklahoma Medical Research Foundation
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Principal Investigator: Katherine Thanou, MD Oklahoma Medical Research Foundation

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Responsible Party: Oklahoma Medical Research Foundation Identifier: NCT01781611     History of Changes
Other Study ID Numbers: IRB# 12-10
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Oklahoma Medical Research Foundation:

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents