NCT00731302

Brief Summary

This study examine whether patients with lupus respond to aspirin , and if not, if that is related to inflammation. We examine the ability of aspirin to inhibit the production of thromboxane in patients with lupus and controls and see if aspirin insensitive thromboxane production is inhibited by meloxicam.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

April 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

12 years

First QC Date

August 5, 2008

Last Update Submit

August 3, 2017

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • thromboxane

    a hormone of the prostacyclin type released from blood platelets. It induces platelet aggregation and arterial constriction.

    after aspirin and after aspirin plus meloxicam

Study Arms (1)

Aspirin and Meloxicam

EXPERIMENTAL

Arm: Aspirin and Meloxicam Each participant will receive 81 mg aspirin per day for 7 days, followed by meloxicam 7.5 mg daily plus aspirin 81 mg daily for 5 days

Drug: aspirin and meloxicam

Interventions

aspirin and meloxicamDRUG

aspirin 81 mg daily then aspirin 81 mg plus meloxicam 7.5 mg daily

Also known as: generic, not applicable
Aspirin and Meloxicam

Eligibility Criteria

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

You may qualify if:

  • Written Informed consent.
  • Age \>18 yrs.
  • SLE meeting ACR criteria {Tan, Cohen, et al. 1982 1482 /id} for at least 6 months.(SLE group)
  • Stable disease activity as evidenced by no change in immunosuppressive therapy in the past 1 month.
  • If female of childbearing potential must use an effective method of birth control

You may not qualify if:

  • Renal disease (creatinine \>1.5 mg/dL, dialysis, 2+ or more proteinuria)
  • Previous or current history of peptic ulcer disease or gastrointestinal bleed.
  • Previous or current thromboembolic or ischemic cardiovascular event (stroke, myocardial infarction, angina) - can do aspirin part of study.
  • Currently taking an anticoagulant or antiplatelet agent (besides aspirin).
  • Thrombocytopenia (platelet count \<135,000)
  • Pregnancy
  • Allergy to aspirin, NSAIDs
  • NSAIDs in the previous week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Vanderbilt University Medical School

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Kawai VK, Avalos I, Oeser A, Oates JA, Milne GL, Solus JF, Chung CP, Stein CM. Suboptimal inhibition of platelet cyclooxygenase 1 by aspirin in systemic lupus erythematosus: association with metabolic syndrome. Arthritis Care Res (Hoboken). 2014 Feb;66(2):285-92. doi: 10.1002/acr.22169.

    PMID: 24022862RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

AspirinMeloxicamDrugs, Generic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiazinesSulfur CompoundsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPharmaceutical Preparations

Study Officials

  • C M Stein, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dan May Professor of Medicine, Professor of Pharmacology, Associate Director of the Division of Clinical Pharmacology

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

April 1, 2005

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

US(2)