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

Not Applicable

Completed

• Conditions: Antiphospholipid Antibody Syndrome
• Interventions: Drug: Celecoxib; Drug: Acetaminophen; Drug: Rofecoxib; Drug: placebo

• Registration Number: NCT01762891
• Lead Sponsor: Hospital Universitario Pedro Ernesto

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2006-07
• Study Completion: 2009-09
• Study First Submitted: 2009-09-24
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-06
• Last Update Submitted: 2013-01-06
• Study First Posted: 2013-01-08
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celecoxib	Rofecoxib	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.
Celecoxib	placebo	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.
Celecoxib	Celecoxib	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.
Celecoxib	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
International Normalized Ratio	increase or decrease on the INR after coxibs or placebo use during 15 days	The outcome measure was verified 15 days after each intervention.