Study identification

EU PAS number

EUPAS105202

Study ID

105203

Official title and acronym

Effectiveness and safety of rivaroxaban and amlodipine dual therapy compared to phenprocoumon and amlodipine dual therapy in non-valvular atrial fibrillation patients - using German health claims data

DARWIN EU® study

No

Study countries

Germany

Study description

This is a retrospective cohort study of NVAF patients receiving a dual therapy of either rivaroxaban with amlodipine at specified doses or phenprocoumon with amlodipine in a real-world setting, where amlodipine is prescribed for the treatment of hypertension. The study focuses on effectiveness, safety outcomes, the drug utilization pattern, and patient characteristics for patients initiating treatment between years 2011 and 2019 using German claims data. The main objective of this study is to describe the effectiveness and safety associated with the use of rivaroxaban and amlodipine when compared to phenprocoumon and amlodipine. An analysis of relevant clinical and demographical data including subgroup analysis will be performed using a representative population from the German health claims data. The primary objective is to evaluate the effectiveness of rivaroxaban using a composite endpoint of prevention of ischemic stroke or systemic embolism. The safety of rivaroxaban and amlodipine will be assessed as a secondary objective based on the risk of bleeding at specific doses compared to dual therapy with phenprocoumon and amlodipine.

Study status

Planned

Contact details

Ravi Iyer

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceutical, R&amp,D, Inc.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable