NOAC Portuguese Real World Study

NCT04808934 | Withdrawn FDA Drug

• 1 other identifier: X9001275
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stroke; Systemic Embolism; Major Bleeding

Outcome Measures

Primary Outcomes (2)

• stroke/systemic embolism event

  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

  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 Outcomes (6)

• ischemic stroke event

  between 2014 and 2018

• hemorrhagic stroke event

  between 2014 and 2018

• systemic embolism event

  2014-2018

• major GI bleeding event

  2014-2018

• major IC bleeding event

  2014-2018

Study Arms (1)

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; Drug: dabigatran; Drug: rivaroxaban; Drug: VKAs

Interventions

Apixaban DRUG

Adults receiving apixaban

Non-Valvular Atrial Fibrillation (NVAF) Adults

dabigatran DRUG

Adults receiving dabigatran

Non-Valvular Atrial Fibrillation (NVAF) Adults

rivaroxaban DRUG

Adults receiving rivaroxaban

Non-Valvular Atrial Fibrillation (NVAF) Adults

VKAs DRUG

Adults receiving VKA

Non-Valvular Atrial Fibrillation (NVAF) Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Biospecimen

Retention: NONE RETAINED

Not applicable, this is a retrospective study

MeSH Terms

Conditions

Stroke

Interventions

apixaban; Dabigatran; Rivaroxaban

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share