Ischemic Heart DiseasePhase 4NCT00565500
Celecoxib, Ibuprofen and the Antiplatelet Effect of Aspirin
A Phase 4 study testing celecoxib and ibuprofen in people with Ischemic Heart Disease and Osteoarthritis, run by University of Chieti at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease, Osteoarthritis
- What is being tested?
- celecoxib and ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2003to Apr 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ce.S.I., Center of Excellence on Aging, G. d'Annunzio University
Chieti, CH, 66100
About this study
Official title: A Placebo-Controlled, Double-Blind, Randomized Study of the Potential Interaction Between Aspirin and Ibuprofen or Celecoxib.
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.
- Conditions
- Ischemic Heart Disease, Osteoarthritis
- Medical subject headings
- Myocardial Ischemia, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
celecoxib capsules 200 mg bid for 1 week
ibuprofenDrug
ibuprofen tablets 600 mg tid for 1 week
placeboDrug
placebo capsules tid for 1 week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: celecoxib |
| 2 | Experimental | Not described Receives: Drug: ibuprofen |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum thromboxane (TX)B2
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startApr 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chieti
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Raffaele De Caterina, MD, PhD, Principal investigator, Institute of Cardiology, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565500
- Sponsor's protocol ID
- 635-IFL-0508-017
- Other IDs
- N49-98-71-900
- Status last verified
- Nov 2007
- First submitted
- 29 Nov 2007
- Last updated
- 30 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
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 11157642Patrignani 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 7045161Catella-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 11752357FitzGerald 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Randomized Study of the Potential Interaction Between Aspirin and Ibuprofen or Celecoxib.
- ClinicalTrials.gov ID
- NCT00565500
- Acronym / sponsor ID
- 635-IFL-0508-017
- Conditions
- Ischemic Heart Disease, Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChietiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2003
- Study completion
- Apr 2005 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: celecoxib |
| 2 | Experimental | Drug: ibuprofen |
| 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxibcelecoxib capsules 200 mg bid for 1 week | Drug | 1 |
| ibuprofenibuprofen tablets 600 mg tid for 1 week | Drug | 2 |
| placeboplacebo capsules tid for 1 week | Drug | 3 |
Primary outcome
serum thromboxane (TX)B2
Time frame: 1 week
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2007.
- Background: PubMed 11157642Patrono 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.
- Background: PubMed 7045161Patrignani 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.
- Background: PubMed 11752357Catella-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.
- Background: PubMed 11496855FitzGerald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele De Caterina, MD, PhD principal investigator
Institute of Cardiology, G. d'Annunzio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing celecoxib and ibuprofen in people with Ischemic Heart Disease and Osteoarthritis, run by University of Chieti at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum thromboxane (TX)B2 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565500, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2007.