Back to results

Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

Primary Purpose

Ischemic Heart Disease, Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

celecoxib

ibuprofen

placebo

About this trial

This is an interventional basic science trial for Ischemic Heart Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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;
history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer;
known hypersensitivity to COX-2 inhibitors, analgesics, antipyretics, sulfonamides or NSAIDs;
treatment with any investigational drug within the previous 30 days;
previous participation in this study;
evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness;
clinically relevant deviations from the normal range in laboratory tests;
recent history or suspicion of alcohol abuse or drug addiction;
subjects unlikely to be collaborative or to give reliable answers;
pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method;
any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial;
intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ACE- inhibitor, lithium, methotrexate, cimetidine, digoxin;
contraindications to NSAIDs.

Sites / Locations

Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

serum thromboxane (TX)B2

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00565500

First Posted

November 29, 2007

Last Updated

November 29, 2007

Sponsor

University of Chieti

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00565500

Brief Title

Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

Official Title

A Placebo-Controlled, Double-Blind, Randomized Study of the Potential Interaction Between Aspirin and Ibuprofen or Celecoxib.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Chieti

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease, Osteoarthritis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

celecoxib

Intervention Description

celecoxib capsules 200 mg bid for 1 week

Intervention Type

Drug

Intervention Name(s)

ibuprofen

Intervention Description

ibuprofen tablets 600 mg tid for 1 week

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

placebo capsules tid for 1 week

Primary Outcome Measure Information:

Title

serum thromboxane (TX)B2

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male or female, age 18-75; subjects with osteoarthritis and documented stable ischemic heart disease; the patient is on long-term aspirin prophylaxis for the ischemic condition; the patient requires or is eligible for chronic treatment with an antiinflammatory and/or analgesic drugs given to control osteoarthritis symptoms; female subjects of childbearing potential must have a negative pregnancy test, use adequate contraception during the study and not be lactating; written informed consent before undergoing any study procedure. Exclusion Criteria: 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; history of active peptic ulceration, gastrointestinal bleeding, esophageal, gastric or duodenal ulcer; known hypersensitivity to COX-2 inhibitors, analgesics, antipyretics, sulfonamides or NSAIDs; treatment with any investigational drug within the previous 30 days; previous participation in this study; evidence of neoplasm or any other severe disease of any organ, including any psychiatric illness; clinically relevant deviations from the normal range in laboratory tests; recent history or suspicion of alcohol abuse or drug addiction; subjects unlikely to be collaborative or to give reliable answers; pregnancy or lactation; female or childbearing potential without a clinical accepted contraceptive method; any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial; intake of antiaggregant, anticoagulant, diuretic, beta-blocker, ACE- inhibitor, lithium, methotrexate, cimetidine, digoxin; contraindications to NSAIDs.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raffaele De Caterina, MD, PhD

Organizational Affiliation

Institute of Cardiology, G. d'Annunzio University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University

City

Chieti

State/Province

ZIP/Postal Code

66100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

11157642

Citation

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.

Results Reference

background

PubMed Identifier

7045161

Citation

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.

Results Reference

background

PubMed Identifier

11752357

Citation

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.

Results Reference

background

PubMed Identifier

11496855

Citation

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.

Results Reference

background

Learn more about this trial

Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin

We'll reach out to this number within 24 hrs