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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01781611 |
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Date of registration:
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02/01/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE)
DARE |
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Scientific title:
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Dipyridamole Assessment for Flare Reduction in SLE |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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18 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01781611 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Katherine Thanou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oklahoma Medical Research Foundation |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: 81mg aspirin
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Drug: extended release dipyridamole 200mg/aspirin 25mg
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Primary Outcome(s)
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British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA)
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Systemic Lupus Erythematosus Responder Index (SRI) 4
[Time Frame: 24 weeks]
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SRI Component Analyses: 4 Point Drop in SLEDAI
[Time Frame: 24 weeks]
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Secondary ID(s)
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IRB# 12-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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