Trial | NCT00222638  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination
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.
Study Started
Oct 31
2004
Study Completion
May 31
2005
Last Update
Sep 22
2005
Estimate

Drug Influenza vaccination

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
No Results Posted