NOAC Portuguese Real World Study

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04808934
• Other study ID #: X9001275
• Status: Withdrawn
• Start date: June 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Hemorrhage
• Major Bleeding
• Stroke
• Systemic Embolism

Intervention

Drug:
• Apixaban
Adults receiving apixaban
• dabigatran
Adults receiving dabigatran
• rivaroxaban
Adults receiving rivaroxaban
• VKAs
Adults receiving VKA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ischemic stroke event	To compare the risk of ischemic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.	between 2014 and 2018
Secondary	hemorrhagic stroke event	To compare the risk of hemorrhagic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.	between 2014 and 2018
Secondary	systemic embolism event	To compare the risk of systemic embolism among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.	2014-2018
Secondary	major GI bleeding event	To compare the risk of major GI bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.	2014-2018
Secondary	major IC bleeding event	To compare the risk of major IC bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.	2014-2018
Secondary	other major bleeding event	To compare the risk of other major bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.	2014-2018