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Influenza Vaccination and Oral Anticoagulant Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222638
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Information provided by:
University Of Perugia

Brief Summary:
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination

Condition or disease Intervention/treatment Phase
Anticoagulants Influenza Vaccines Drug: Influenza vaccination Phase 4

Detailed Description:
The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy
Study Start Date : October 2004
Study Completion Date : May 2005





Primary Outcome Measures :
  1. 1.Variations in INR value and in OAT weekly dosage after IV

Secondary Outcome Measures :
  1. 1.Efficacy of IV in patients on OAT


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OA Treatment
  • Stable anticoagulation (previous two controls in range)
  • Presence of indication for Influenza Vaccination
  • Life expectancy > 6 months
  • Signed Informed consent

Exclusion Criteria:

  • Absence of stable anticoagulation
  • Absence of indication for Influenza Vaccination
  • Life expectancy < 6 months
  • Denied Informed Consent

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): NCT00222638


Locations
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Italy
University of Perugia
Perugia, Italy, 06100
Sponsors and Collaborators
University Of Perugia
Investigators
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Principal Investigator: Alfonso Iorio University Of Perugia
Principal Investigator: Maria Vecchioli Regional Sanitary Agency (ASL2-Perugia)
Principal Investigator: Anna Maria Iorio Institute of Virology - University of Perugia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00222638    
Other Study ID Numbers: 04 MICV AI 01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: June 2005
Keywords provided by University Of Perugia:
Oral anticoagulants
Influenza virus
Influenza vaccine
Pharmacological interference
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs