Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
NCT ID: NCT02145546
Last Updated: 2014-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2014-05-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amiodarone
Patient will take Amiodarone orally
Amiodarone
Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
Sotalol
Patients will take sotalol orally
Sotalol
80mg twice per day.
Propafenone
Patients will take propafenone orally
Propafenone
150mg per 8 hours, 3 times per day
Control
Patients will take no antiarrhythmic drugs except β-blocker
No interventions assigned to this group
Interventions
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Amiodarone
Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
Propafenone
150mg per 8 hours, 3 times per day
Sotalol
80mg twice per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sick sinus syndrome with pacemaker Class I or Class IIa indication
* has a pacemaker which can provide the daily AF burden monitor record for at least 28 days
* has at AF record in the past 6 months, the valid AF record includes any of
1. at least one 30 seconds AF holter record
2. at least one 15 seconds 12-ECG record
3. at least 5 minutes long AF episodes record from pacemakers
* able and willing to give informed consent
Exclusion Criteria
* NYHA Class III or IV
* LVEF \<50%
* Reversible AF, such as AF caused by hyperthyroidism or severe postoperative atrial fibrillation
* Persistence AF
* Expected life expectancy less than 1 year
* Planned to be pregnant or be in the feeding period in the next year
* Non-stable, decompensated heart failure
* Allergy to Amiodarone, Propafenone or Sotalol
* Cancer
* Clear liver damage ( ALT and/or AST \> 2\*normal limit)
* Patients with cardiogenic shock history
* Be in the treatment of Amiodarone for more than 3 months or less than 3 months with Amiodarone wash out period less than 30 days
* Coronary artery disease (CHD), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (COPD), long QT syndrome
18 Years
ALL
No
Sponsors
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Medtronic (Shanghai) Management Co. Ltd.
INDUSTRY
Beijing CTSmed Co. Ltd
UNKNOWN
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Yi-Gang Li
Chief Physician
Principal Investigators
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Yi-Gang Li, MD
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiaotong University School of Medicne
Locations
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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OSTRANDER LD Jr, BRANDT RL, KJELSBERG MO, EPSTEIN FH. ELECTROCARDIOGRAPHIC FINDINGS AMONG THE ADULT POPULATION OF A TOTAL NATURAL COMMUNITY, TECUMSEH, MICHIGAN. Circulation. 1965 Jun;31:888-98. doi: 10.1161/01.cir.31.6.888. No abstract available.
Zhou ZQ, Hu DY, Chen J, Zhang RH, Li KB, Zhao XL. [An epidemiological survey of atrial fibrillation in China]. Zhonghua Nei Ke Za Zhi. 2004 Jul;43(7):491-4. Chinese.
Siu CW, Jim MH, Zhang X, Chan YH, Pong V, Kwok J, Kung AW, Lau CP, Tse HF. Comparison of atrial fibrillation recurrence rates after successful electrical cardioversion in patients with hyperthyroidism-induced versus non-hyperthyroidism-induced persistent atrial fibrillation. Am J Cardiol. 2009 Feb 15;103(4):540-3. doi: 10.1016/j.amjcard.2008.10.019. Epub 2008 Dec 25.
Singh BN, Singh SN, Reda DJ, Tang XC, Lopez B, Harris CL, Fletcher RD, Sharma SC, Atwood JE, Jacobson AK, Lewis HD Jr, Raisch DW, Ezekowitz MD; Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T) Investigators. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med. 2005 May 5;352(18):1861-72. doi: 10.1056/NEJMoa041705.
Roy D, Talajic M, Dorian P, Connolly S, Eisenberg MJ, Green M, Kus T, Lambert J, Dubuc M, Gagne P, Nattel S, Thibault B. Amiodarone to prevent recurrence of atrial fibrillation. Canadian Trial of Atrial Fibrillation Investigators. N Engl J Med. 2000 Mar 30;342(13):913-20. doi: 10.1056/NEJM200003303421302.
Pritchett EL, Page RL, Carlson M, Undesser K, Fava G; Rythmol Atrial Fibrillation Trial (RAFT) Investigators. Efficacy and safety of sustained-release propafenone (propafenone SR) for patients with atrial fibrillation. Am J Cardiol. 2003 Oct 15;92(8):941-6. doi: 10.1016/s0002-9149(03)00974-3.
Israel CW. Analysis of mode switching algorithms in dual chamber pacemakers. Pacing Clin Electrophysiol. 2002 Mar;25(3):380-93. doi: 10.1046/j.1460-9592.2002.00380.x.
Passman RS, Weinberg KM, Freher M, Denes P, Schaechter A, Goldberger JJ, Kadish AH. Accuracy of mode switch algorithms for detection of atrial tachyarrhythmias. J Cardiovasc Electrophysiol. 2004 Jul;15(7):773-7. doi: 10.1046/j.1540-8167.2004.03537.x.
Kaufman ES, Israel CW, Nair GM, Armaganijan L, Divakaramenon S, Mairesse GH, Brandes A, Crystal E, Costantini O, Sandhu RK, Parkash R, Connolly SJ, Hohnloser SH, Healey JS; ASSERT Steering Committee and Investigators. Positive predictive value of device-detected atrial high-rate episodes at different rates and durations: an analysis from ASSERT. Heart Rhythm. 2012 Aug;9(8):1241-6. doi: 10.1016/j.hrthm.2012.03.017. Epub 2012 Mar 20.
Nowak B, McMeekin J, Knops M, Wille B, Schroder E, Moro C, Oelher M, Castellanos E, Coutu B, Petersen B, Pfeil W, Kreuzer J; Stored EGM in PulsarMax II and Discovery II Study Group. Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms. Pacing Clin Electrophysiol. 2005 Jul;28(7):620-9. doi: 10.1111/j.1540-8159.2005.00159.x.
Charles D. Swerdlow, Jeffrey M. Gillberg, Paul Khairy, Textbook, Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy, Chapter 3, Sensing and Detection, page 146.
Other Identifiers
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XHEC-C-2013-013-2
Identifier Type: -
Identifier Source: org_study_id
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