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

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ClinicalTrials.gov Identifier: NCT01762891
Recruitment Status : Completed
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Veronica Silva Vilela, Hospital Universitario Pedro Ernesto

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.

Condition or disease Intervention/treatment Phase
Antiphospholipid Antibody Syndrome Drug: Celecoxib Drug: Acetaminophen Drug: Rofecoxib Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.
Study Start Date : March 2003
Actual Primary Completion Date : July 2006
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: Celecoxib
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.
Drug: Celecoxib
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: celebrex

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

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

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

Primary Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762891

Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
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Principal Investigator: Veronica S Vilela, MD Hospital Universitario Pedro Ernesto
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Responsible Party: Veronica Silva Vilela, Physician, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01762891    
Other Study ID Numbers: 32323232
Pfizer ( Other Grant/Funding Number: Pharmaceutic company )
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Veronica Silva Vilela, Hospital Universitario Pedro Ernesto:
antiphospholipid syndrome and INR
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action