Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation (ADA-PAF)
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|ClinicalTrials.gov Identifier: NCT02145546|
Recruitment Status : Unknown
Verified May 2014 by Yi-Gang Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Not yet recruiting
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Amiodarone Drug: Propafenone Drug: Sotalol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2017|
Patient will take Amiodarone orally
Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
Patients will take sotalol orally
80mg twice per day.
Patients will take propafenone orally
150mg per 8 hours, 3 times per day
No Intervention: Control
Patients will take no antiarrhythmic drugs except β-blocker
- Average AF burden in minutes per day [ Time Frame: monthly up to 12 months ]Long term usages of test drug reduce AF burden, including the number and accumulated total time of AF per day.
- Persistent AF free survival rate [ Time Frame: monthly up to12 months ]Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。
- Left ventricular function [ Time Frame: 0months, 6months and 12 months ]LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume
- SF-36 health survey [ Time Frame: 0 months, 6 months and 12 months ]SF-36 health survey
- comorbidity and mortality [ Time Frame: 6 months and 12 months ]The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate.
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): NCT02145546
|Contact: Yi-Gang Li, MDfirstname.lastname@example.org|
|Contact: Bo Liu, MDemail@example.com|
|Xinhua Hospital, Shanghai Jiao Tong University School of Medicne||Not yet recruiting|
|Shanghai, Shanghai, China, 200092|
|Principal Investigator: Yi-Gang Li, MD|
|Principal Investigator:||Yi-Gang Li, MD||Xinhua Hospital, Shanghai Jiaotong University School of Medicne|