Influenza Vaccination and Oral Anticoagulant Therapy

University Of Perugia

Status and phase: Completed; Phase 4

Conditions: Influenza Vaccines; Anticoagulants

Treatments: Drug: Influenza vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT00222638

04 MICV AI 01

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind