AzTrials
AzTrials

Atrial FibrillationMISSION-AFNCT02414035

Monitor System for the Safety of Dabigatran Treatment

An observational study of Atrial Fibrillation, run by Second Affiliated Hospital of Nanchang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
How many people
1,496 participants
Where
1 siteChina
Study dates
22 Mar 2015to 18 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Age>18 y at entry
  • 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
  • In addition to documented AF, patients must have ≥1 CHADS2-VAS scores
  • We identified participants as those diagnosed as having AF, and who initiated dabigatran after diagnosis
  • Written, informed consent

Who cannot join

  • History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
  • Severe, disabling stroke, or any stroke within the previous 14d
  • Acute coronary syndrome within 1 year in AF patients
  • Conditions associated with an increased risk of bleeding
  • Major surgery in the previous month
  • History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
Show all 12Show fewer
  • Gastrointestinal hemorrhage or hematuria
  • Severe renal impairment (estimated creatinine clearace≤30ml/min)
  • Severe liver dysfunction
  • Alcohol abuse or drug addiction
  • Patients who have received an investigational drug at this time
  • Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trail

Trial locations and contacts

1 site in 1 country.

China1 site

  • The second hospital affillated of Nanchang University

    Nanchang, Jiangxi, 330006

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
atrial fibrillation, anticoagulation, Dabigatran
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major bleeding events

    Any of the following events happened: intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for gastrointestinal, hematuria,or NOS hemorrhage

    Measured: up to 12 months (or) years

  2. Minor bleeding events

    Any of the following events happened: epistaxis, hemoptysis, vaginal hemorrhage, hemarthrosis and any outpatient claim for hematuria, gastrointestinal, and NOS hemorrhage.

    Measured: up to 12 months (or) years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2015 (estimated)
  2. Study start22 Mar 2015
  3. Primary completionMar 2018
  4. Study completion18 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,496 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414035
Sponsor's protocol ID
2014ZX09303305
Acronym
MISSION-AF
Status last verified
Sep 2019
First submitted
25 Mar 2015
Last updated
23 Sep 2019
Results posted
No
Data monitoring committee
No

Publications

  • Oldgren J, Healey JS, Ezekowitz M, Commerford P, Avezum A, Pais P, Zhu J, Jansky P, Sigamani A, Morillo CA, Liu L, Damasceno A, Grinvalds A, Nakamya J, Reilly PA, Keltai K, Van Gelder IC, Yusufali AH, Watanabe E, Wallentin L, Connolly SJ, Yusuf S; RE-LY Atrial Fibrillation Registry Investigators. Variations in cause and management of atrial fibrillation in a prospective registry of 15,400 emergency department patients in 46 countries: the RE-LY Atrial Fibrillation Registry. Circulation. 2014 Apr 15;129(15):1568-76. doi: 10.1161/CIRCULATIONAHA.113.005451. Epub 2014 Jan 24.

    PubMed 24463370

  • Steinberg BA, Piccini JP. Anticoagulation in atrial fibrillation. BMJ. 2014 Apr 14;348:g2116. doi: 10.1136/bmj.g2116.

    PubMed 24733535

  • Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2. doi: 10.1016/j.ahj.2009.02.005.

    PubMed 19376304

  • Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, Ezekowitz MD, Nehmiz G, Wang S, Wallentin L; RE-LY Investigators. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol. 2014 Feb 4;63(4):321-8. doi: 10.1016/j.jacc.2013.07.104. Epub 2013 Sep 27.

    PubMed 24076487

  • Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015 Jan 13;131(2):157-64. doi: 10.1161/CIRCULATIONAHA.114.012061. Epub 2014 Oct 30.

    PubMed 25359164

  • Zhou W, Wang T, Zhu LJ, Wen MH, Hu LH, Huang X, You CJ, Li JX, Wu YQ, Wu QH, Bao HH, Cheng XS. Peripheral leukocyte count and risk of bleeding in patients with non-valvular atrial fibrillation taking dabigatran: a real-world study. Chin Med J (Engl). 2019 Sep 20;132(18):2150-2156. doi: 10.1097/CM9.0000000000000423.

    PubMed 31490268

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Second Affiliated Hospital of Nanchang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major bleeding events (time frame: up to 12 months (or) years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414035, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in