Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

NCT ID: NCT04435769

Last Updated: 2023-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2021-05-31

Brief Summary

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To describe the direct costs related to warfarin/apixaban treatment

Detailed Description

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To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-valvular Atrial Fibrillation (NVAF) on warfarin

The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.

No interventions assigned to this group

Non-valvular Atrial Fibrillation (NVAF) on apixaban

The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of non-valvular atrial fibrillation (NVAF);
* New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
* Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
* Apixaban arm: genetically determined higher sensitivity to warfarin;
* Patients whose status allowed oral treatment with apixaban/warfarin;
* Age ≥ 18;
* Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Exclusion Criteria

* Diagnosis of valvular disease;
* Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
* Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
* Contraindications according SmPC of Eliquis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Fakultní nemocnice Motol

Prague, , Czechia

Site Status

Countries

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Czechia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B0661121

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Other Identifiers

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APIXABAN SECOND LINE

Identifier Type: OTHER

Identifier Source: secondary_id

B0661121

Identifier Type: -

Identifier Source: org_study_id

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