NOAC Portuguese Real World Study

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04808934

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Systemic Embolism Major Bleeding	Drug: Apixaban Drug: dabigatran Drug: rivaroxaban Drug: VKAs

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Apixaban Adults receiving apixaban Drug: dabigatran Adults receiving dabigatran Drug: rivaroxaban Adults receiving rivaroxaban Drug: VKAs Adults receiving VKA

Arm

Intervention/Treatment

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.

Drug: Apixaban

Adults receiving apixaban

Drug: dabigatran

Adults receiving dabigatran

Drug: rivaroxaban

Adults receiving rivaroxaban

Drug: VKAs

Adults receiving VKA

Outcome Measures

Primary Outcome Measures

stroke/systemic embolism event [between 2014 and 2018]
To compare the risk of stroke (either ischemic or hemorrhagic) or SE among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major bleeding event [between 2014 and 2018]
To compare the risk of major bleeding (gastrointestinal [GI], intracranial [IC] and other) among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versusVKAs.

Secondary Outcome Measures

ischemic stroke event [between 2014 and 2018]
To compare the risk of ischemic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
hemorrhagic stroke event [between 2014 and 2018]
To compare the risk of hemorrhagic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
systemic embolism event [2014-2018]
To compare the risk of systemic embolism among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major GI bleeding event [2014-2018]
To compare the risk of major GI bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
major IC bleeding event [2014-2018]
To compare the risk of major IC bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
other major bleeding event [2014-2018]
To compare the risk of other major bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT04808934

Other Study ID Numbers:

X9001275

First Posted:

Mar 22, 2021

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022