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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02864758
Other study ID # 18656
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 8, 2016
Est. completion date September 30, 2018

Study information

Verified date November 2023
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran


Description:

Main objective: To compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran. Secondary objectives: - To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users, as well as and pattern of use; - To compare the one-year and two-year risk of the following individual outcomes: a composite of stroke and SE, major bleeding and death, clinically relevant bleeding (CRB) and acute coronary syndrome (ACS) between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran; - To estimate the cumulative incidence and the incidence rate of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according to individual diagnose of each of these outcomes, during drug exposure for rivaroxaban, dabigatran, and VKA; - To estimate the cumulative incidence of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according individual diagnose of each of these outcomes during post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation); - To assess outcome risk factors, including (but not limited to), gender, age, stroke and bleeding risk scores (CHA2DS2-VASc and HAS-BLED), low or high dosage at index date for DOAC, drug predisposing to bleeding during drug exposure and significant baseline characteristics; - To describe and compare healthcare resources utilisation related to SPAF during rivaroxaban, dabigatran, and VKA exposure, including outcomes, and their related costs from the societal perspective and from the French healthcare insurance perspective.


Recruitment information / eligibility

Status Completed
Enrollment 99999
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 99 Years
Eligibility Inclusion Criteria: - Definite non-valvular atrial fibrillation: - A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and - No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years, - Definite AF information in the database Probable non-valvular atrial fibrillation:- - A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and - No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years, - Probable AF information in the database (using the development of an AF disease score, see variables definition below), Exclusion Criteria: - Patients with Rheumatic valve disease - Patients with valve replacement - Patients treated with anticoagulants for venous - thromboemboslim or prevention of venous - thromboembolism after orthopedic surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rivaroxaban (Xarelto, BAY59-7939)
Tablets, 20mg once daily
Vitamin K antagonists
Tablets, dose is based on International Normalized Ratio
dabigatran (Pradaxa)
Tablets, 150 mg twice daily

Locations

Country Name City State
France Many Locations Multiple Locations

Sponsors (2)

Lead Sponsor Collaborator
Bayer Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

France, 

References & Publications (1)

Blin P, Fauchier L, Dureau-Pournin C, Sacher F, Dallongeville J, Bernard MA, Lassalle R, Droz-Perroteau C, Moore N. Effectiveness and Safety of Rivaroxaban 15 or 20 mg Versus Vitamin K Antagonists in Nonvalvular Atrial Fibrillation. Stroke. 2019 Sep;50(9):2469-2476. doi: 10.1161/STROKEAHA.119.025824. Epub 2019 Aug 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stroke and systemic embolism (Effectiveness outcome) Hospitalization with ischemic or undefined stroke or other systemic arterial embolism or surgical procedure for systemic arterial embolism To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran. One year and Two Year
Primary Major Bleeding Hospitalization with haemorrhagic stroke, other critical organ or site bleeding (intraspinal, intraocular,retroperitoneal, intraarticular or pericardial, or intramuscular), Other bleeding with a transfusion during hospital stay, or resulting in death.
To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
One year and Two Year
Primary Death All-cause death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran. One year and Two Year
Secondary Pattern of use (Exposure, Adherence, Discontinuation, Switch) To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users and pattern of use Up to two years
Secondary A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban vs VKA, and rivaroxaban vs dabigatran One year and Two Year
Secondary Cumulative incidence and incidence rate of stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes During drug exposure for rivaroxaban, dabigatran, and VKA Up to two years
Secondary Cumulative incidence of Stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes Post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation) Up to two years
Secondary Healthcare resources utilisation Healthcare resources use will be described from reimbursed claims and hospitalisation information Healthcare resources cost will be estimated using the French HAS methodological guide for economic evaluations (2011) Up to two years
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