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Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Phase 0
35 Years
90 Years
Open (Enrolling)
Tobacco Use Disorder, Smoking

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Trial Information

Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Inclusion Criteria:

- Male gender

- Age ≥35

- Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)

- Former smoker, quit no more than 15 years ago with a history of at least 25 py

- Ability to comply with the design of the study

- Capacity to freeze urine sample at participant's residence if this participant
desires to store the urine specimens in this manner

- Baseline urine PGE-M > 13 ng/mg creatinine

- Serum thromboxane > 150 μg/L

Exclusion Criteria:

- History of aspirin use 1-14 days prior to screening

- NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening

- Inhaled glucocorticoid use 1-7 days prior to screening

- Systemic glucocorticoid use 1-14 days prior to screening

- History of peptic ulcer disease

- Current or recent clinically significant bleeding

- Allergy, intolerance or contraindication to aspirin or NSAID use

- Thrombocytopenia (platelet count < 100,000) in 30 days prior to screening visit

- Severe hepatic insufficiency

- GFR < 30 mL/min/1.73 m2 in 30 days prior to screening visit

- History of aspirin or celecoxib allergy

- Elevated INR (>1.5) in 30 days prior to screening visit

- Current diagnosis of malignancy or history of non-skin malignancy in last 5 years

- Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin
(Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))

- Diagnosis of COPD

- Intake of > 250 mg of fish oil supplementation daily

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment

Outcome Description:

Baseline urinary PGE-2 metabolite (PGE-M) will be measured. Then after 3 days of COX-2 blockade with celecoxib, it will again be measured. Participants will then undergo 10 days of treatment with aspirin and urinary PGE-M will be measured. Finally, participants will be treated with combined aspirin and celecoxib for 3 days and urinary PGE-M will be measured one last time. Using these values, the degree of aspirin inhibition of COX-2 specific urinary PGE-M production can be calculated.

Outcome Time Frame:

16 days

Safety Issue:


Principal Investigator

John A Oates, MD

Investigator Role:

Study Director

Investigator Affiliation:

Vanderbilt University


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Tobacco Use Disorder
  • Smoking
  • Smoking
  • Tobacco Use Disorder



Vanderbilt University Nashville, Tennessee  37232-6305