CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen

Study Overview
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Brief Summary
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Coumadin drug-drug interactions (DDI) are frequent. Patients in permanent use of coumadin are advised to avoid traditional nonsteroidal antiinflammatory drugs to avoid risk of bleeding. New selctive cyclooxygesase 2 inhibitors arisen as potential option for treating pain and inflamation in these patients once interactions with coumadin are supposed to be lower. The CI(R)CA study was made to evaluate in a prospective fashion the occurrence of DDI with new cyclooxygenase antiinflammatory drugs and coumadin when compared to acetaminophen and placebo.

Detailed Description
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The CI(R)CA study included patient diagnosed with antiphospholipid syndrome in permanent use of coumadin. Eligible patients were invited to use in a prospective cross-over mode two weeks of celecoxib, rofecoxib, acetaminophen and placebo with two weeks of wash out between drugs. Their international normalized ratio (INR) were measured before and during the use of each study drug. The interaction with coumadin was evaluated according to increases or decreases on the INR after each medication.

Official Title
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CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.

Conditions
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Antiphospholipid Antibody Syndrome

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Acetaminophen
* Drug: Rofecoxib
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PAPS on contious stable dose of coumadin 18 years old or older Younger than 65 yo Signed informed consent. Exclusion Criteria: Renal failure Heart failure Symptomatic gastritis or peptic ulcer Elevated liver enzymes (>3 fold) Platelet count < 100,000.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Celecoxib 200mg/day oral rout Intervention: celecoxib 200mg oral rout administered durng 15 days and followed by administration of rofecoxib 25mg/day during 15 days, placebo 15 days and acetaminophen 3g/day during 15 days. | Drug: Celecoxib<br>* celecoxib 200mg/day by oral rout during 15 days followed by the administration of rofecoxib 25mg/day, acetaminophen 3g/day and placebo during 15 days each drug.<br>* Other names: celebrex;Drug: Acetaminophen<br>* Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.<br>* Other names: Tylenol;Drug: Rofecoxib<br>* Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.<br>* Other names: Vioxx;Drug: placebo<br>* Placebo pills were given during 15 days by oral rout as one of the four interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Normalized Ratio | The outcome measure was verified 15 days after each intervention. | increase or decrease on the INR after coxibs or placebo use during 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coumadin, celecoxib, rofecoxib, acetaminophen, antiphospholipid syndrome and INR