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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Pedro Ernesto
• Treatments: Acetaminophen; Celecoxib; Rofecoxib; Warfarin

Criteria

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.