NCT01781611

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

November 25, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

4.2 years

First QC Date

January 2, 2013

Results QC Date

October 9, 2020

Last Update Submit

November 3, 2020

Conditions

Systemic Lupus Erythematosus

Keywords

lupusdipyridamole

Outcome Measures

Primary Outcomes (1)

  • British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA)

    This is a landmark measure of percentage of patients who meet response criteria. To meet the BICLA response measure a patient must, compared to baseline, have a decrease in all moderate or severe scores on the British Isles Lupus Assessment Group (BILAG) index by at least one severity grade (Severe disease (BILAG A score) must drop to at least moderate (B or better) and B must drop to at least mild (C or not present). Also, there must be no increase in any other BILAG organ scores, no increase in The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score, and no increase in the physician's global assessment (PGA) by more than 10% of the scale. Furthermore, there may no off protocol medication increases. Note on all scales mentioned a higher score signifies greater disease activity. Ranges on BILAG could be 0-108 but are rarely greater than 36. SLEDAI could range 0-105 but is rarely greater than 20. PGA 0-100 but rarely greater than 76.

    24 weeks

Secondary Outcomes (2)

  • Systemic Lupus Erythematosus Responder Index (SRI) 4

    24 weeks

  • SRI Component Analyses: 4 Point Drop in SLEDAI

    24 weeks

Study Arms (2)

extended release dipyridamole/aspirin

EXPERIMENTAL

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

Drug: extended release dipyridamole 200mg/aspirin 25mg

aspirin

ACTIVE COMPARATOR

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

Drug: 81mg aspirin

Interventions

extended release dipyridamole 200mg/aspirin 25mgDRUG

one tablet twice daily for 24 weeks

Also known as: Aggrenox
extended release dipyridamole/aspirin
81mg aspirinDRUG

half a tablet twice daily for 24 weeks

Also known as: ASA
aspirin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

  • 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.

    PMID: 21437870BACKGROUND

  • 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.

    PMID: 33687069DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

AspirinAspirin, Dipyridamole Drug Combination

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDipyridamolePyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Joan T. Merrill, M.D.
Organization
Oklahoma Medical Research Foundation
joan-merrill@omrf.org
405-822-2336

Study Officials

  • Katherine Thanou, MD

    Oklahoma Medical Research Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

February 1, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2017

Study Completion

November 1, 2017

Last Updated

November 25, 2020

Results First Posted

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Those who wish access to this data may contact Joan Merrill at joan-merrill@omrf.org for further information

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available on or before June 1 2021
Access Criteria
For de-identified data only: Please submit a two page request describing the research you wish to do and the investigators credentials and current employment. This will be reviewed by our cohort advisory board and IRB prior to release.

Locations

US(1)