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

Hospital Universitario Pedro Ernesto

Status: Completed

Conditions: Antiphospholipid Antibody Syndrome

Treatments: Drug: placebo; Drug: Celecoxib; Drug: Rofecoxib; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01762891

32323232

Pfizer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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22 participants in 1 patient group

Celecoxib

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: Rofecoxib

Drug: Celecoxib

Drug: placebo