Antiphospholipid Antibody Syndrome
Conditions
Keywords
Coumadin, celecoxib, rofecoxib, acetaminophen, antiphospholipid syndrome and INR
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.
Interventions
DRUGCelecoxib
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.
DRUGAcetaminophen
Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
DRUGRofecoxib
Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
DRUGplacebo
Placebo pills were given during 15 days by oral rout as one of the four interventions.
Sponsors
Hospital Universitario Pedro Ernesto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed