NCT02414035

Monitor System for the Safety of Dabigatran Treatment

A Monitor System for the Safety of Dabigatran Anticoagulation Treatment in Nonvalvular Atrial Fibrillation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,496 (actual)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether dabigatran is associated with higher risk of bleeding in Asia area especially in China clinical practice and whether it need to set up a monitor system.

Detailed description

Dabigatran is administered in a fixed does without laboratory monitoring and is being compared with warfarin (international normalized ratio, but only hundreds of evidence from Asia events in several multicenter, prospective, randomized trails. It remains unclear that whether Dabigatran is safety in China clinical practice and no need of monitor test. We identified participants as those diagnosed as having nonvalved atrial fibrillation, and who initiated dabigatran after diagnosis.We followed up each individual from the first prescription of dabigatran until discontinued use or switch of anticoagulants, death, or other outcomes or until one year later. We categorized bleeding events as major and minor events according to anatomical position. We defined time to bleeding as days between the first dabigatran prescription and the date of the bleeding event. We analyzed the time to the first bleeding event, as well as the time to the first major hemorrhage, intracranial hemorrhage, gastrointestinal bleeding, hematuria, vaginal bleeding, hemarthrosis, hemoptysis, and epistaxis.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2015-03-22
• Primary completion: 2018-03-01
• Completion: 2018-04-18
• First posted: 2015-04-10
• Last updated: 2019-09-23

Locations

1 site across 1 country: China