| CTRI Number |
CTRI/2013/12/004238 [Registered on: 23/12/2013] Trial Registered Prospectively |
| Last Modified On: |
24/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to determine the effectiveness and safety of a new drug Ibutilide in the management of rhythm disorders of the heart. |
|
Scientific Title of Study
|
An open, multicentric prospective clinical trial to evaluate the efficacy and safety of Ibutilide fumarate injection in the treatment of Atrial Fibrillation or Flutter. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/CARD/IBUT/05/2011 version no 1 Date: 05/12/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Yadav |
| Designation |
Principal Investigator |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences,
Room N0: 102, 1st floor old O.T. Block,
Anasari Nagar
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
rakeshyadav123@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
zuventus healthcare Ltd
office no 5119, 5th floor D wing oberoi garden estate chandivali andheri east mumbai
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
zuventus healthcare Ltd
office no 5119, 5th floor D wing oberoi garden estate chandivali andheri east mumbai
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh.dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
| Zuventus Healthcare limited |
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
Office no 5119, 5th floor D wing oberoi garden estate chandivali andheri east Mumbai 72 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Yadav |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences,
Room N0: 102, O.T. Block,
Anasari Nagar, New Delhi- 110029
New Delhi
DELHI |
9126594579
rakeshyadav123@yahoo.com |
| Dr Kamal Sharma |
Ankur Superspeciality Hospital |
A/3-3, Vijay Tower, Ankur Commercial Complex,Ankur Cross Road, Naurangpura, Ahmedabad-380013
Ahmadabad
GUJARAT |
09426020154
kamalsharma1975@rediffmail.com |
| Dr Shailender Singh |
Kamineni Hospital |
4-1-1227, King koti, Hyderabad-500001
Hyderabad
ANDHRA PRADESH |
09848022021
coo.khs@kaminenihospitals.com |
| Dr Chandra Bhan |
S.M.S.Medical Collegeand Hospital |
SAWAI MAN SINGH HOSPITAL & MEDICAL COLLEGE,
J.L.N. Marg, Jaipur, Rajasthan- 302004
Jaipur
RAJASTHAN |
09414250934
drcbhan@gmail.com |
| Dr Aditya Kapoor |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Dept. of cardiologySanjay Gandhi Post Graduate Institute of Medical Sciences,Raibareli Rd, Lucknow - 226002
Lucknow
UTTAR PRADESH |
09839008893
akapoor65@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sunshine Hospital |
Approved |
| Institutional Ethics Committee, AIIMS |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi PGIMS, Lucknow |
Approved |
| Office of the Ethics Committeee (EC) SMS Medical College & Attached Hospitas, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I48||Atrial fibrillation and flutter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ibutilide Fumarate Injection 0.1mg/ml |
1 mg infused over 10 min (administered once during the entire study). Additional 1mg infusion over 10 mins may be administered 10 min following the initial dose if sinus rhythm (SR) is not achieved. |
| Comparator Agent |
not Applicable |
open label non comparative trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Above 18 yrs of age, with no previous exposure to investigational drug.
2.Weighing > 60 kg
3.Patients with sustained Atrial Fibrillation or Flutter lasting for >1hr to <60 days.
4.Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1-7 days after surgery).
5.Corrected QT interval (QTc) ≤440 ms on a 12 lead electrocardiogram (ECG).
6.Haemodynamic stability (systolic blood pressure ≥90 mm Hg and diastolic blood pressure ≥60 mm Hg and < 105 mm Hg).
7.Ventricular rate >60bpm
|
|
| ExclusionCriteria |
| Details |
1.History of Hyperthyroidism.
2.Heart Rate <60 bpm.
3.History or evidence of unstable angina pectoris, bronchospastic disease or myocardial infarction.
4.Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block, Wolff-Parkinson-White syndrome and/or torsade de pointes.
5.Concurrent treatment with verapamil, diltiazem, or drugs that prolong the QT interval
6.Recent major hemorrhage (within 6 months).
7.Coagulopathy
8.Pregnant or breast feeding
9.Acute congestive heart failure
10.Hypokalemia or hyperkalemia (Electrolyte abnormalities)
11.Polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I
12.Left ventricular ejection fraction < 40%
13.Serum creatinine levels >2.5mg/dL
14.Liver function test > 2 times the upper limit of normal value
15.History of chronic renal failure or a creatinine clearance of < 30ml/min.
16.Known hypersensitivity to investigational drug or its components. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving cardio version after intravenous administration of Ibutilide. |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events observed during the treatment period |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
not published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open, multicentric prospective clinical trial to
evaluate the efficacy and safety of Ibutilide fumarate injection in the treatment
of Atrial Fibrillation or Flutter.The
aim of the study is to establish efficacy and safety of Ibutilide fumarate in
the treatment of Atrial Fibrillation or Flutter in Indian patients
120 adult Indian patients with Atrial
Fibrillation or Flutter will be enrolled in this study. Enrollment will
continue until 100 evaluable subjects with Atrial Fibrillation or Flutter
complete the study.
|