Monitor System for the Safety of Dabigatran Treatment

NCT02414035 | Completed

• 1 other identifier: 2014ZX09303305
• Study Type: observational
• Target: 1,496
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; anticoagulation; Dabigatran

Outcome Measures

Primary Outcomes (2)

• Major bleeding events

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

The second hospital affillated of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (6)

• 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.

  PMID: 24463370 BACKGROUND

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

  PMID: 24733535 BACKGROUND

• 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.

  PMID: 19376304 BACKGROUND

• 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.

  PMID: 24076487 BACKGROUND

• 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.

  PMID: 25359164 BACKGROUND

• 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.

  PMID: 31490268 DERIVED

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.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiao s Cheng, MD,PhD

  The second hospital affillated of Nanchang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 10, 2015
• Study Start: March 22, 2015
• Primary Completion: March 1, 2018
• Study Completion: April 18, 2018
• Last Updated: September 23, 2019

Record last verified: 2019-09

Locations

CN (1)