| CTRI Number |
CTRI/2009/091/000026 [Registered on: 16/02/2009] |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
An extension study to establish long term safety of dabigatran in patients with atrial fibrillation, and to evaluate the effect of knowledge translation intervention on patient outcomes. |
Scientific Title of Study
Modification(s)
|
Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 1160.71 |
Other |
| NCT00808067 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Supriya Dalvi |
| Designation |
|
| Affiliation |
|
| Address |
IQVIA RDS (India) Private Limited , 301-A-1, Leela Business Park,
M V Road, Andheri (E),
Mumbai
MAHARASHTRA
400059
India |
| Phone |
022-66774261 |
| Fax |
022-66774343 |
| Email |
Supriya.Dalvi@Quintiles.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Boehringer Ingelheim Korea Ltd.,Korea |
|
Primary Sponsor
Modification(s)
|
| Name |
Boehringer Ingelheim Korea Ltd |
| Address |
16F, Yonsei severance Bldg, 84-11 Namdaemunro-5Ka, Chung-Ku, Seoul, Korea |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
Republic of Korea
Canada
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Naik |
Care Institute of Medical Sciences |
Off Science City Road, Opp. Panchamrut Bunglow, Sola, Ahmedabad-380060
Ahmadabad
GUJARAT |
09825082666
079-26872620
birely@gmail.com |
| Dr. Johny Joseph |
Consultant Cardiologist, Caritas Hospital |
Thellakom (P.O.) ,-686 016
Kottayam
KERALA |
09447124948
0481 2790163
relycaritas@gmail.com |
| Dr. K. K. Haridas |
Department of Cardiology, Amrita Institute of Medical Sciences and Research Centre (AIMS) |
Elamakkara (P.O.),-682 026
|
09447118500
0484 2802133
rely@aims.amrita.edu |
| Dr. Rakesh Kumar Aggarwal |
Department of Cardiology, Christian Medical College & Hospital |
Brown Road,-141008
Ludhiana
PUNJAB |
09814215692
0161 2228568
jaisonsally@gmail.com |
| Dr Sudeep Kumar |
Department of Cardiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Raebareli Road,-226014
Lucknow
UTTAR PRADESH |
0522-2494384
0522-2668017
iec@sgpgi.ac.in |
| Dr Prem Pais |
Department of Cardiology, St.Johns Medical College Hospital |
Sarjapur Road,-560 034
Bangalore
KARNATAKA |
09844130406
080-25530737
relysjmch@gmail.com |
| Dr. J. P. S. Sawhney |
Dharamvira Heart Centre, Sir Gangaram Hospital |
Old Rajender Nagar,-110060
New Delhi
DELHI |
09810059773
011 42437230
birely_dvhc@yahoo.co.in |
| Dr. B. Ramesh Babu |
Medwin Hospital |
Nampally,-500001
Hyderabad
ANDHRA PRADESH |
09848308889
040 23203868
Kiranmayi_rely@yahoo.com |
| Dr. Jagdish Hiremath |
Poona Hospital & Research Centre |
27, Sadashiv Peth,-411030
Pune
MAHARASHTRA |
09822022441
020-24338181
bi_rely@yahoo.co.in |
| Dr. J B Gupta |
S R Kalla Memorial Gastro & General Hospital, |
78, Dhuleshwar Garden,C Scheme-302001
Jaipur
RAJASTHAN |
09829414680
01412378914
jbgbirely@rediffmail.com |
| Dr. Shrenik Shah |
Sterling Hospital |
Sterling Hospital Road,,Memnagar-380052
Ahmadabad
GUJARAT |
079-40011111
079 4001 1622
|
| Dr Arun Srinivas |
Vikram Hospital & Heartcare, |
46, Vivekanand Road, Yadavagiri-570020
Mysore
KARNATAKA |
09845028387
0821-4255533
vhcardquintiles@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethics Committee - Caritas Hospital, Kottayam-Dr. Johny joseph |
Approved |
| Ethics Committee - Dharamvira Heart Centre, Sir Gangaram Hospital , New Delhi - Dr. J. P. S. Sawhney |
Approved |
| Ethics Committee - Poona Hospital & Research Centre, Pune - Dr. Jagdish Hiremath |
Approved |
| Ethics Committee - Sterling Hospital, Ahmedabad-Dr. Shrenik Shah |
Approved |
| Ethics Committee of the Heart Care Clinic, Ahmedabad-Dr.Ajay Naik |
Approved |
| Ethics Committee- Christian Medical College & Hospital, Ludhiana-Dr. R.K.Aggarwal |
Approved |
| Ethics Committee- S. R. Kalla Memorial Ethical Committee for Human Research, Jaipur-Dr.J.B.Gupta |
Approved |
| Institutional Ethical Review Board SJMCH, Bangalore-Dr. Prem Pais |
Approved |
| Institutional Ethics Committee - Medwin Hospital, Hyderabad-Dr. Ramesh Babu |
Approved |
| Institutional Ethics Committee - Sanjay Gandhi Post Graduate Institute of Medical Sciences, Ludhiana - Dr Sudeep Kumar |
Approved |
| Institutional Ethics Committee- AIMS, Kochi- Dr. K K Haridas |
Approved |
| Vikram Hospital Ethics committee, Mysore-Dr. Arun Srinivas |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Atrial Fibrillation, (1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Dabigatran etexilate |
110mg or 150mg b.i.d. for up to 28 months |
| Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients are eligible for this study if they meet the following criteria:
1. Randomization to dabigatran in RE-LY and not permanently discontinued from dabigatran at the time of RE-LY termination visit
2. Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation.
3. Written, informed consent
|
|
| ExclusionCriteria |
| Details |
1. Need for anticoagulant treatment for disorders other than atrial fibrillation
2. Plan to perform a pulmonary vein ablation or surgery for cure of AF
3. Patients with prosthetic heart valves requiring anticoagulation differing from an INR of 2.0?3.0
4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the 30 days prior to the start of this trial
5. Severe renal impairment (estimated creatinine clearance ≤30 mL/min) based upon last results available from RE-LY 1160.26 (should be from within the past year)
6. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L) based upon last results available from RE-LY 1160.26 (should be from within the past year).
7. Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg)
8. Active liver disease, including known hepatitis A, B or C
9. Active infective endocarditis
10. Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
11. Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study.
12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration (i.e., demonstrated study drug compliance of less than 80% in RE-LY or was noncompliant with study visits in RE-LY), or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
13. Current use of quinidine |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Knowledge translation:
Primary endpoints: Vascular death, stroke, myocardial infarction, non- non-CNS systemic embolism, major bleeding and hospitalization for heart failure.
|
Maximum 28 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Secondary endpoints:
Stroke (including hemorrhagic), non-CNS systemic embolism, pulmonary embolism, acute MI, DVT, and all deaths (includes deaths from bleeding)
|
Maximum 28 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="261"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
21/01/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
16/12/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is to establish the long term safety of dabigatran etexilate and to assess the effect of a knowledge translation intervention on the prognosis, cardiovascular risk profile and quality of care in patients with atrial fibrillation (AF). A total of 261 patients are proposed to be to be recruited from India. |