Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 10:05 PM
Study NCT ID:
NCT02414035
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitor System for the Safety of Dabigatran Treatment
Sponsor:
Second Affiliated Hospital of Nanchang University
Organization:
Study Overview
Official Title:
A Monitor System for the Safety of Dabigatran Anticoagulation Treatment in Nonvalvular Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MISSION-AF
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: