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Completed

NCT Number: NCT01762891

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.

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Key information

Conditions

Antiphospholipid Antibody Syndrome Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

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 names: celebrex

Acetaminophen

Drug

Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.

Other names: Tylenol

Rofecoxib

Drug

Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.

Other names: Vioxx

Placebo

Drug

Placebo pills were given during 15 days by oral rout as one of the four interventions.

Primary outcomes

  1. International Normalized Ratio

    Time frame: increase or decrease on the INR after coxibs or placebo use during 15 days

    The outcome measure was verified 15 days after each intervention.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Pedro Ernesto

Other

Registry information

Official study title

CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.

Acronym: CI(R)CA

Important dates

Study start
2003
Primary completion
2006
Study completion
2009
First posted
Jan 8, 2013
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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