| 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
|
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 |
| Trial Acronym |
IBUTILIDE PHASE IV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/CARD/IBUT/IV/2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director, Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| 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 of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director, Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| 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 of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director, Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| 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
|
| 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
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
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
ANDHRA PRADESH |
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
WEST BENGAL |
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
UTTAR PRADESH |
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
UTTAR PRADESH |
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
MAHARASHTRA |
9867936579
prasitapk@yahoo.com |
| Dr Anand Ahuja |
Rhythm Heart Institute |
Department of Cardiology,
Near Siddharth Bungalows,
Sama-Savali Road,
Vadodara- 390022
Gujarat
Vadodara
GUJARAT |
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
KARNATAKA |
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
|
|
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 |
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
|
| 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"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/01/2018 |
| Date of Study Completion (India) |
19/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|