NOAC Portuguese Real World Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-01

Brief Summary

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To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists

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Detailed Description

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Conditions

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Stroke Systemic Embolism Major Bleeding

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-Valvular Atrial Fibrillation (NVAF) Adults

Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018.

Apixaban

Intervention Type DRUG

Adults receiving apixaban

dabigatran

Intervention Type DRUG

Adults receiving dabigatran

rivaroxaban

Intervention Type DRUG

Adults receiving rivaroxaban

VKAs

Intervention Type DRUG

Adults receiving VKA

Interventions

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Apixaban

Adults receiving apixaban

Intervention Type DRUG

dabigatran

Adults receiving dabigatran

Intervention Type DRUG

rivaroxaban

Adults receiving rivaroxaban

Intervention Type DRUG

VKAs

Adults receiving VKA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years on the index date.
* At least 1 OAC (apixaban, dabigatran, rivaroxaban, VKAs) dispensed during the identification period.

Exclusion Criteria

* Specialty of the physician responsible for the OAC prescription in the index date is one of the following: orthopedics, general surgery, vascular surgery or any other surgical specialty;
* Duration of OAC therapy during follow-up inferior to the cut-off defined during the feasibility assessment (except if the patient was admitted to in-hospital care during follow-up);
* The OAC dispensed in the index date was one of the following: dabigatran 75 mg or rivaroxaban 10 mg
* Hospital claims lacking a diagnosis code indicative of AF during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of pregnancy or childbirth during the study period;
* Hospital claim indicating a diagnosis or procedure code indicative of valvular heart disease, venous thromboembolism, cardiac surgery, pericarditis, hyperthyroidism and thyrotoxicity during the baseline period;
* Hospital claim indicating a diagnosis or procedure code indicative of hip and knee replacement surgery during the 6 weeks prior to the index date. Patients with past use of OAC will be excluded. Therefore, patients meeting any of the following criteria will be excluded:
* Had any OAC (apixaban, dabigatran, edoxaban, rivaroxaban, VKAs) dispensed during the 12-month baseline period;
* Had \>1 OAC dispensed on the index date.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No