CTRI Number	CTRI/2018/01/011248 [Registered on: 10/01/2018] Trial Registered Prospectively
Last Modified On:	19/07/2022
Post Graduate Thesis	No
Type of Trial	PMS
Type of Study	Drug
Study Design	Single Arm Study
Public Title of Study Modification(s)	determination of efficacy and safety of Ibutilde in patients with abnormal heart rythm
Scientific Title of Study	An Open-Label, Multicentre, Prospective, Phase- IV Study to Evaluate the Efficacy and Safety of Ibutilide Fumarate Injection (0.1mg/ml) in the Treatment of Atrial Fibrillation and Flutter
Secondary IDs if Any Modification(s)	Secondary ID  Registry  ZUV/CARD/IBUT/IV/2016  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Bhupesh Dewan  Address  Office No 5119 ‘D’ wing,5th Floor Oberoi Garden Estates Chandivali Andheri east Mumbai 400072 Mumbai MAHARASHTRA 400072 India  Phone  022-30610000   Fax     Email  Bhupesh.Dewan@zuventus.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Bhupesh Dewan  Address  Office No 5119 ‘D’ wing,5th Floor Oberoi Garden Estates Chandivali Andheri east Mumbai 400072 Mumbai MAHARASHTRA 400072 India  Phone  022-30610000   Fax     Email  Bhupesh.Dewan@zuventus.com
Details Contact Person Public Query Modification(s)	Name  Dr Bhupesh Dewan  Address  Office No 5119 ‘D’ wing,5th Floor Oberoi Garden Estates Chandivali Andheri east Mumbai 400072 Mumbai MAHARASHTRA 400072 India  Phone  022-30610000   Fax     Email  Bhupesh.Dewan@zuventus.com
Source of Monetary or Material Support Modification(s)	Zuventus Healthcare Limited Office No. 5119, 5th Floor, D Wing, Oberoi Garden Estates, Chandivili, Andheri (E), Mumbai - 400 072.
Primary Sponsor	Name  Zuventus Healthcare Limited  Address  Oberoi Garden Estate Sakinaka Andheri East Chandivali Farm Road Powai Mumbai Maharashtra 400072   Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 7   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr A Gopal Rao  Government Medical College & Government General Hospital (Old RIMSGGH)  Department of Medicine, Srikakulam, Andhra Pradesh 532 001 Srikakulam   9440122790 drgopalraoa@gmail.com  Dr Saroj Mandal  Institute of Post Graduate Medical Education and research and SSKM hospital  Department Of Cardiology, Institute of Cardiovascular Sciences, 244, Acharya Jagdish Chandra Bose road, Kolkata, West Bengal 700020 Kolkata   9831313714 drsarojkumarr@gmail.com  Dr Akshyaya Pradhan   King George’s Medical University, Lucknow  Department Of Cardiology, King Georges Medical University, Lucknow-226003 Uttar Pradesh Lucknow   8400813739 akshyaya33@gmail.com  Dr Mohmadullah Razi  LPS Institute Of Cardiology, Kanpur  2nd floor, Department of cardiology,LPS Institute Of Cardiology, GSVM Medical college,Rawatpur, Kanpur 208019 Kanpur Nagar   7408427786 drmmrazi@gmail.com  Dr Prasita Kshirsagar  Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital  Room No. 9 & 10, 2nd Floor, Department of Medicine, Kalwa, Thane-400605, Maharashtra Thane   9867936579 prasitapk@yahoo.com  Dr Anand Ahuja  Rhythm Heart Institute  Department of Cardiology, Near Siddharth Bungalows, Sama-Savali Road, Vadodara- 390022 Gujarat Vadodara   9825582680 ahujaanand1@rediffmail.com  Dr Sunil Dwivedi  Vikram Hospital, Bangalore  Department Of Cardiology, #71/1,Millers road,Opp to st Annes college,bengaluru 560052 Bangalore   9845132745 anushkaeshaan@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 7   Name of Committee  Approval Status  Ethics Committee , GSVM Medical College  Approved  IEC Govt Medical college and Gen Hospital  Approved  Institutional Clinical Ethics Committee  Approved  Institutional Ethics Committee, KGMU  Approved  IPGMER Research Oversight Committee  Approved  Rythm Heart Institute Ethics Committee  Approved  Vikram Hospital Bangalore Pvt Ltd Ethics Committtee  Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Atrial fibrillation and flutter
Intervention / Comparator Agent	Type  Name  Details  Intervention  ibutilide  Ibutilide fumarate injection(0.1 mg/mL) 1 mg infused over 10 minutes. Additional 1mg infusion over 10 minutes may be administered after waiting for 10 minutes following the initial dose if cardioversion is not achieved  Comparator Agent  nil  nil
Inclusion Criteria Modification(s)	Age From  19.00 Year(s) Age To  85.00 Year(s) Gender  Both  Details  Patients >18 yrs of age Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to <90 days. Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery). Corrected QT interval (QTc) ≤ 440 ms on a 12 lead electrocardiogram (ECG). Haemodynamic stability ( systolic blood pressure ≥ 90 mm Hg and diastolic blood pressure ≥ 60 mm Hg and < 105 mm Hg). Absence of structural heart disease Ventricular rate >60bpm
ExclusionCriteria	Details  Known hypersensitivity to ibutilide injection or its components like sulphonamides or sulfa drugs. Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block and/or torsades de pointes. Patient with documented evidence of atrial clot formation. Severely Anaemic patients (Hb < 8.0 g/dL) Pregnant or breast feeding Grade III & IV congestive heart failure Serum potassium <3.5 mEq/L or serum magnesium <1.5 mEq/L Severe hepatic, hematologic, metabolic, renal, gastrointestinal, central nervous system, psychiatric, or other disorder that could interfere with the conduct of the study; or compromise safety.
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  To investigate the efficacy of Ibutilide for cardioversion of atrial fibrillation and flutter  Proportion of patients achieving cardioversion (sinus rhythm) after intravenous administration of Ibutilide fumarate injection. Mean Time to achieve cardioversion
Secondary Outcome	Outcome  TimePoints  To evaluate the safety of the Ibutilide in Indian patients  Proportion of patients who remained in sinus rhythm at 24 hours post dose Adverse events observed during the study period
Target Sample Size	Total Sample Size="120" Sample Size from India="120"
Phase of Trial	Phase 4
Date of First Enrollment (India) Modification(s)	25/01/2018
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	none yet
Brief Summary	An open label, multicentre, prospective phase- IV study to evaluate the efficacy and safety of Ibutilide fumarate injection (0.1mg/ml) in the treatment of Atrial Fibrillation and Flutter The aim of this study is to establish the efficacy and safety of Ibutilide fumarate in the treatment of Atrial Fibrillation and Flutter in Indian patients. 120 adult Indian patients with Atrial Fibrillation or Flutter will be enrolled in this study The study duration will be of 24 hours. After administration of the required dose of Ibutilide, the patient will be observed in intensive care unit for 24 hours.