Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran | NCT02331602 | Trialant

Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran | NCT02331602 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rivaroxaban	Active Comparator	Patients are assigned to receive rivaroxaban 15mg once daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.	Drug: Rivaroxaban
dabigatran	Active Comparator	Patients are assigned to receive dabigatran 150mg twice daily for 12 months according to a computer-generated randomization sequence at the central registration center. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.	Drug: Dabigatran

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban	Drug	Patients are assigned to receive rivaroxaban 15mg once daily for 12 months. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
median variation of inflammatory markers (including high sensitivity C reactive protein, pentraxin3, interleukin-6, and interleukin-18) between at baseline and 12 months later in each treatment group		12 months

Secondary Outcomes

Measure	Description	Time Frame
change over time of above inflammatory markers during 12 months follow-up period (at baseline, 1 month, 3 months, 6 months, and 12 months later) in each treatment group		12 months

Other Outcomes

Measure	Description	Time Frame
frequency of 12-month adverse cardiac and cerebrovascular events (including cardiovascular death, myocardial infarction, revascularization, ischemic stroke and systemic embolism)and frequency of 12-month major bleeding (defined as ISTH criteria)		12 months

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