NOAC Portuguese Real World Study

April 4, 2023 updated by: Pfizer

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients will be selected from the CCF database based on an apixaban, dabigatran, rivaroxaban or VKAs filled prescription between June 16, 2014 and December 31, 2018.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
stroke/systemic embolism event
Time Frame: 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.
between 2014 and 2018
major bleeding event
Time Frame: 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.
between 2014 and 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ischemic stroke event
Time Frame: between 2014 and 2018
To compare the risk of ischemic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
between 2014 and 2018
hemorrhagic stroke event
Time Frame: between 2014 and 2018
To compare the risk of hemorrhagic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
between 2014 and 2018
systemic embolism event
Time Frame: 2014-2018
To compare the risk of systemic embolism among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
2014-2018
major GI bleeding event
Time Frame: 2014-2018
To compare the risk of major GI bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
2014-2018
major IC bleeding event
Time Frame: 2014-2018
To compare the risk of major IC bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
2014-2018
other major bleeding event
Time Frame: 2014-2018
To compare the risk of other major bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
2014-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • X9001275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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