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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Second Affiliated Hospital of Nanchang University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414035
First Posted: April 10, 2015
Last Update Posted: April 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Second Affiliated Hospital of Nanchang University
  Purpose
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.

Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Monitor System for the Safety of Dabigatran Anticoagulation Treatment in Nonvalvular Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Second Affiliated Hospital of Nanchang University:

Primary Outcome Measures:
  • 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

  • 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.


Biospecimen Retention:   Samples With DNA
Samples with DNA for genetic variants test which could contribute to interindividual variability in blood concentrations of the active metabolite of dabigatran etexilate and influence the safety and efficacy of dabigatran.

Estimated Enrollment: 2000
Study Start Date: March 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414035


Contacts
Contact: Xiao s Cheng, MD,PhD 079186268844 xiaoshumenfan@126.com
Contact: Xiao Huang, MD,PhD 8613767161642 drxiaohuang@163.com

Locations
China, Jiangxi
The second hospital affillated of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Xiao S Cheng, MD,PhD    079186268844    xiaoshumenfan@126.com   
Sponsors and Collaborators
Second Affiliated Hospital of Nanchang University
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
  More Information

Publications:

Responsible Party: Second Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT02414035     History of Changes
Other Study ID Numbers: 2014ZX09303305
First Submitted: March 25, 2015
First Posted: April 10, 2015
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Second Affiliated Hospital of Nanchang University:
atrial fibrillation
anticoagulation
Dabigatran

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants