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CompletedNCT00565500Updated Nov 30, 2007

Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

A Phase 4 interventional study of celecoxib and ibuprofen in Ischemic Heart Disease and Osteoarthritis, sponsored by University of Chieti. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-11-30.

Sponsored by University of Chieti · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Study design: Single center, placebo-controlled, double blind, parallel groups. To evaluate the potential interaction between aspirin and ibuprofen or celecoxib in patients with osteoarthritis (OA) and documented stable ischemic heart disease, a total of 24 patients chronically treated with aspirin will be randomly assigned to one of the 3 treatment groups: 1) celecoxib 200 mg bid; 2) ibuprofen 600 mg tid; 3) placebo.

Read the detailed description

Patients with arthritis and vascular disease may receive both NSAIDs and lowdose aspirin for the secondary prevention of important vascular events. The use of COX-2 inhibitors may have the potential advantage vs. nonselective NSAIDs in reducing the probability of interfering with permanent inactivation of COX-1 platelet by low-dose aspirin, in this setting. In fact, recent studies suggest that the likelihood of COX-inhibitors to present this pharmacodynamic interaction is inversely related to their COX-2 selectivity. Thus, differently from the non-selective NSAID ibuprofen, prior administration of the selective COX-2 inhibitor rofecoxib, does not antagonize the irreversible inhibition induced by aspirin in healthy subjects. Aim of this study is to determine whether celecoxib given at therapeutic dose at steady state alters the antiplatelet activity of low-dose aspirin, in comparison with ibuprofen.

02

Conditions studied

  • Ischemic Heart Disease
  • Osteoarthritis
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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 24 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

This is the only study on the registry with University of Chieti as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. male or female, age 18-75;
  2. subjects with osteoarthritis and documented stable ischemic heart disease;
  3. the patient is on long-term aspirin prophylaxis for the ischemic condition;
  4. the patient requires or is eligible for chronic treatment with an antiinflammatory and/or analgesic drugs given to control osteoarthritis symptoms;
  5. female subjects of childbearing potential must have a negative pregnancy test, use adequate contraception during the study and not be lactating;
  6. written informed consent before undergoing any study procedure.

Exclusion criteria

Exclusion Criteria:

  1. active gastrointestinal disease (e.g. Crohn's disease or ulcerative colitis) or any evidence of concomitant disease which may lead to early termination of the study;
  2. history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer;
  3. known hypersensitivity to COX-2 inhibitors, analgesics, antipyretics, sulfonamides or NSAIDs;
  4. treatment with any investigational drug within the previous 30 days;
  5. previous participation in this study;
  6. evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
  7. clinically relevant deviations from the normal range in laboratory tests;
  8. recent history or suspicion of alcohol abuse or drug addiction;
  9. subjects unlikely to be collaborative or to give reliable answers;
  10. pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method;
  11. any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial;
  12. intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ACE- inhibitor, lithium, methotrexate, cimetidine, digoxin;
  13. contraindications to NSAIDs.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    1

    Drug: celecoxib

  • Experimental
    2

    Drug: ibuprofen

  • Placebo comparator
    3

    Drug: placebo

Interventions

  • Drugcelecoxib

    celecoxib capsules 200 mg bid for 1 week

  • Drugibuprofen

    ibuprofen tablets 600 mg tid for 1 week

  • Drugplacebo

    placebo capsules tid for 1 week

06

What researchers measure

Primary outcomes

  1. serum thromboxane (TX)B2

    Time frame: 1 week

Secondary outcomes

  1. urinary 11-dehydro-thromboxane (TX)B2, arachidonic acid- and ADP-induced platelet aggregation by Born's aggregometer, whole-blood aggregation in the platelet function analyzer (PFA) system, LPS-stimulated prostaglandin(PG)E2

    Time frame: 1 week

07

Study locations

1 site
  • Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University
    Chieti, CH 66100, Italy
08

References and documents

Publications

  • Patrono C, Coller B, Dalen JE, FitzGerald GA, Fuster V, Gent M, Hirsh J, Roth G. Platelet-active drugs : the relationships among dose, effectiveness, and side effects. Chest. 2001 Jan;119(1 Suppl):39S-63S. doi: 10.1378/chest.119.1_suppl.39s. No abstract available. PubMed 11157642 ↗
  • Patrignani P, Filabozzi P, Patrono C. Selective cumulative inhibition of platelet thromboxane production by low-dose aspirin in healthy subjects. J Clin Invest. 1982 Jun;69(6):1366-72. doi: 10.1172/jci110576. PubMed 7045161 ↗
  • Catella-Lawson F, Reilly MP, Kapoor SC, Cucchiara AJ, DeMarco S, Tournier B, Vyas SN, FitzGerald GA. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl J Med. 2001 Dec 20;345(25):1809-17. doi: 10.1056/NEJMoa003199. PubMed 11752357 ↗
  • FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med. 2001 Aug 9;345(6):433-42. doi: 10.1056/NEJM200108093450607. No abstract available. PubMed 11496855 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00565500
Lead sponsor
University of Chieti
Collaborators
Pfizer
First posted
Nov 30, 2007
Start date
Apr 2003
Completion
Apr 2005
Last update
Nov 30, 2007

Study contacts

Raffaele De Caterina, MD, PhD
principal investigator · Institute of Cardiology, G. d'Annunzio University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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