Monitor System for the Safety of Dabigatran Treatment (MISSION-AF)

September 19, 2019 updated by: Second Affiliated Hospital of Nanchang University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1496

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The second hospital affillated of Nanchang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We identified participants as those diagnosed as having artrial fibrillation, and who initiated dabigatran after diagnosis. The diagnosis of AF was defined as having inpatient or outpatient claims with primary or secondary International Classification of Diseases, Ninth Revision(ICD-9), code427.31.12. The CHADS2-VAS score is calculated as the sum of all points for a given patient and need >=1. A history of previous stroke or transient ischemic attack is assigned 2 points; congestive heart failure, hypertension, age of 75 years or older, and diabetes are each assigned 1 point.

Description

Inclusion Criteria:

  1. Age>18 y at entry
  2. AF documented as follows: The patients has a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG, rhythm strip, pacemaker/implantable cardioverter-defibrillator electrogram, or Holter ECG
  3. In addition to documented AF, patients must have ≥1 CHADS2-VAS scores
  4. We identified participants as those diagnosed as having AF, and who initiated dabigatran after diagnosis
  5. Written, informed consent

Exclusion Criteria:

  1. History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
  2. Severe, disabling stroke, or any stroke within the previous 14d
  3. Acute coronary syndrome within 1 year in AF patients

  4. Conditions associated with an increased risk of bleeding

    1. Major surgery in the previous month
    2. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
    3. Gastrointestinal hemorrhage or hematuria
  5. Severe renal impairment (estimated creatinine clearace≤30ml/min)
  6. Severe liver dysfunction
  7. Alcohol abuse or drug addiction
  8. Patients who have received an investigational drug at this time
  9. Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trail

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major bleeding events
Time Frame: up to 12 months (or) years
Any of the following events happened: intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for gastrointestinal, hematuria,or NOS hemorrhage
up to 12 months (or) years
Minor bleeding events
Time Frame: up to 12 months (or) years
Any of the following events happened: epistaxis, hemoptysis, vaginal hemorrhage, hemarthrosis and any outpatient claim for hematuria, gastrointestinal, and NOS hemorrhage.
up to 12 months (or) years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Principal Investigator: Xiao s Cheng, MD,PhD, The second hospital affillated of Nanchang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014ZX09303305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe