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Completed

NCT Number: NCT00222638

Influenza Vaccination and Oral Anticoagulant Therapy

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

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Key information

Conditions

Anticoagulants Infections Influenza Vaccines Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Perugia

Perugia, 06100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Influenza Vaccination

Drug

Primary outcomes

  1. 1.Variations in INR value and in OAT weekly dosage after IV

Secondary outcomes

  1. 1.Efficacy of IV in patients on OAT

Sponsors and collaborators

Lead sponsor

University Of Perugia

Other

Registry information

Official study title

Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy

Important dates

Study start
2004
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Sep 22, 2005

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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