CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen
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.
Antiphospholipid Antibody Syndrome
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.|
- International Normalized Ratio [ Time Frame: increase or decrease on the INR after coxibs or placebo use during 15 days ] [ Designated as safety issue: Yes ]The outcome measure was verified 15 days after each intervention.
|Study Start Date:||March 2003|
|Study Completion Date:||September 2009|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
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 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.
Other Name: celebrexDrug: Acetaminophen
Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
Other Name: TylenolDrug: Rofecoxib
Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
Other Name: VioxxDrug: placebo
Placebo pills were given during 15 days by oral rout as one of the four interventions.
Other Name: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762891
|Principal Investigator:||Veronica S Vilela, MD||Hospital Universitario Pedro Ernesto|