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

NCT ID: NCT01781611

Last Updated: 2020-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-11-30

Brief Summary

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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

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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

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Systemic Lupus Erythematosus

Keywords

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lupus dipyridamole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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extended release dipyridamole/aspirin

extended release dipyridamole 200mg/aspirin 25mg twice daily for 24 weeks

Group Type EXPERIMENTAL

extended release dipyridamole 200mg/aspirin 25mg

Intervention Type DRUG

one tablet twice daily for 24 weeks

aspirin

half a tablet of a 81mg aspirin twice daily for 24 weeks

Group Type ACTIVE_COMPARATOR

81mg aspirin

Intervention Type DRUG

half a tablet twice daily for 24 weeks

Interventions

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extended release dipyridamole 200mg/aspirin 25mg

one tablet twice daily for 24 weeks

Intervention Type DRUG

81mg aspirin

half a tablet twice daily for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Aggrenox ASA

Eligibility 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oklahoma Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Thanou, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Medical Research Foundation

Locations

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Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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Kyttaris VC, Zhang Z, Kampagianni O, Tsokos GC. Calcium signaling in systemic lupus erythematosus T cells: a treatment target. Arthritis Rheum. 2011 Jul;63(7):2058-66. doi: 10.1002/art.30353.

Reference Type BACKGROUND
PMID: 21437870 (View on PubMed)

Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Reference Type DERIVED
PMID: 33687069 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB# 12-10

Identifier Type: -

Identifier Source: org_study_id