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Aspirin Resistance in Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT00731302
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE August 5, 2008
First Posted Date  ICMJE August 8, 2008
Last Update Posted Date August 7, 2017
Study Start Date  ICMJE April 2005
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
thromboxane [ Time Frame: after aspirin and after aspirin plus meloxicam ]
a hormone of the prostacyclin type released from blood platelets. It induces platelet aggregation and arterial constriction.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
thromboxane [ Time Frame: after aspirin and after aspirin plus meloxicam ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Resistance in Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE Vascular Damage in Systemic Lupus Erythematosus (SLE)
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.
Detailed Description Premature cardiovascular disease is a major cause of mortality in patients with systemic lupus erythematosus (SLE) with the risk of myocardial infarction increased up to 50-fold. In addition to defining the mechanisms for accelerated atherosclerosis it is important to define the effects of drugs used to reduce cardiovascular risk in high-risk patients. Low dose aspirin, by inhibiting thromboxane A2 biosynthesis, has profound antiplatelet effects, but some patients have impaired thromboxane suppression - a phenomenon termed aspirin resistance. An explanation is that aspirin-independent thromboxane synthesis may occur through enhanced COX-2 activity, as would occur in an inflammatory condition such as lupus. However, little is known about the effects of low-dose aspirin in SLE. Thus, we propose to test the following hypothesis: 1) that aspirin insensitive thromboxane biosynthesis is increased in patients with lupus and is mediated by increased COX-2 activity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: aspirin and meloxicam
aspirin 81 mg daily then aspirin 81 mg plus meloxicam 7.5 mg daily
Other Name: generic, not applicable
Study Arms  ICMJE Experimental: Aspirin and Meloxicam
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
Intervention: Drug: aspirin and meloxicam
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2008)
120
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion criteria.

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00731302
Other Study ID Numbers  ICMJE HL65082
R01HL065082 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party C. Michael Stein, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: C M Stein, M.D. Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP