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CTRI Number  CTRI/2015/05/005782 [Registered on: 18/05/2015] Trial Registered Retrospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Cluster Randomized Trial 
Public Title of Study   A knowledge translational trial for quality improvement in Atrial fibrillation- IMPACT AF 
Scientific Title of Study   An International Multicenter clustered randomized controlled trial to imProve treatment with AntiCoagulanTs in patients with atrial fibrillation.  
Trial Acronym  IMPACT AF. 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT02082548  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Denis Xavier  
Designation  Head, Department of Pharmacology,  
Affiliation  St. Johns Medical College 
Address  St Johns Medical College and Research Institute Koramangala

Bangalore
KARNATAKA
560034
India 
Phone  08049466141  
Fax  8025633382  
Email  denis@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Alben Sigamani 
Designation  Associate Professor  
Affiliation  Division of Clinical Research and Training, St Johns Research Institute  
Address  St Johns National Academy of Health Sciences, Sarjapur Road, Koramangala Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  08049467080  
Fax  08049467090  
Email  alben@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Kamath  
Designation  Senior Resident 
Affiliation  Division of Clinical Research and Training, St Johns Research Institute  
Address  St Johns National Academy of Health Sciences, Sarjapur Road, Koramangala Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  08049467081  
Fax  08049467090  
Email  kamath.deepak@sjri.res.in  
 
Source of Monetary or Material Support  
Duke Clinical Research Institute 
 
Primary Sponsor  
Name  Duke Clinical Research Institute 
Address  Duke University 2400 Pratt Street Durham NC 27705, USA 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
China
India
Romania  
Sites of Study  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR BHUPENDRA NARAYAN MAHANTA  ASSAM MEDICAL COLLEGE  Associate Professor, Department of Medicine, DIBRUGARH ASSAM
Dibrugarh
ASSAM 		 09435030599
0373-2300080
drbnmahanta@hotmail.com 
DRJOHNY JOSEPH  CARITAS HOSPITAL  HOD & Consultant Cariologist, Department of Cardiology, THELLAKOM PO
Kottayam
KERALA 		 91-9447124948
0481-2790164
drjohnyjoseph@gmail.com 
DR BIDITA KHANDELWAL  CENTRAL REFFERAL HOSPITAL   Professor & HOD Medicine, 0141 Sikkim Medical Council, 5TH MILE TADONG GANGTOK
East
SIKKIM 		 09434241480
03592-231162
drbidita@gmail.com 
DR RAKESH KUMAR AGGARWAL  DEEP HEART HOSPITAL  Consultant Cardiologist, Deep Heart Center, 478 L MODEL TOWN
Ludhiana
PUNJAB 		 09814215692

aggawal.rakeshkumar@yahoo.com 
DR RAJEEV GUPTA  FORTIS ESCORTS HOSPITAL  Senior Consultant & Head Internal Medicine, Director Research & Academics, JAWAHARLAL NEHRU MARG,MALVIYA NAGAR
Jaipur
RAJASTHAN 		 09829068150
0141-2547002
rajeevgg@gmail.com 
DR SANDEEP KUMAR GUPTA  M V CLINIC AND HOSPITAL  Director and Chief Consultant, Department of Internal Medicine, R/O,314/30 MIRZA MANDI CHOWK
Lucknow
UTTAR PRADESH 		 09336077839
0522-4016051
sandeepkumar.gupta@rediffmail.com 
DR BIMAL K AGRAWAL   MM INSTITUTE OF MEDICAL SCIENCES AND RESEARCH   Professor & Head, Department of Medicine, MULLANA
Ambala
HARYANA 		 09466811700
0091-1731274375
bkagrwal2001@yahoo.com 
DR J NARENDRA   NANJAPPA LIFE CARE   Consultant Cardiologist, Department of Cardiology. 5619 GADDIKOPPA SAGAR ROAD
Shimoga
KARNATAKA 		 09448135619
08182-251188
Jnarendra2009@gmail.com 
DR M BHASKARA RAO  QUEENS NRI HOSPITAL   Consultant Interventional Cardiologist, GURUDWARA LANE SEETHAMMADHARA
Visakhapatnam
ANDHRA PRADESH 		 09846624766
0891-2533078
bhaskarstudies@hotmail.com 
DR KAMLESH LILADHAR FATANIA  RATHI HOSPITAL  Consultant Physician NEAR ANUPAM SHOPPING CENTRE OPPOSITE MAHABALESHWAR SOCIETY JODHPUR CROSS ROAD SATELLITE
Ahmadabad
GUJARAT 		 09825466788
079-26924812
drkamlesh_fatania@yahoo.co.in 
DR SOAHAM DESAI   SHREE KRISHNA HOSPITAL AND MEDICAL RESEARCH CENTRE  Assistant Professor, Department of Neurology, GOKAL NAGAR KARAMSAD
Anand
GUJARAT 		 09979937885
02692-222414
soahamdd@charutarhealth.org 
DR KIRON VARGHESE  ST JOHNS MEDICAL COLLEGE AND HOSPITAL  HOD & Professor, Department of Cardiology, 3rd Floor, St. Johns Medical College
Bangalore
KARNATAKA 		 09845167912
91-8025630603
drkiron@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
ETHICSCOMMITTEE-CARITAS HOSPITAL  Approved 
HUMAN RESEARCH ETHICS COMMITTEE SHREE KRISHNA HOSPITAL AND MEDICAL RESEARCH CENTRE  Approved 
INSTITUTE ETHICS COMMITTEE QUEENS NRI HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE ASSAM MEDICAL COLLEGE  Approved 
INSTITUTIONAL ETHICS COMMITTEE FORTIS ESCORTS HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE M V HOSPITAL AND RESEARCH CENTRE  Approved 
Institutional Ethics committee St Johns Medical College   Approved 
M M UNIVERSITY ETHICS COMMITTEE  Approved 
NANJAPPAS INSTITUTIONAL ETHICS COMMITTEE  Approved 
Rathi Ethics Committee  Approved 
SMIMS INSTITUITION ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS OVER AGE OF 18 WITH PAROXYSMAL,PERSISTENT OR PERMANENT ATRIAL FIBRILLATION AND ATLEAST TWO CHA2DS2VASc RISK FACTORS.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational intervention at physician and patient level.  Physician intervention: Provision of updated guidelines (ACC/AHA and NICE guidelines), online webinars and live summits. Webinars: 4 times a year, 2 hrs per webinar. Live summit: Twice a year, 2 gays per summit. Patient level intervention: Trained non physician health worker follow ups, patient education and goal settings. Patient intervention frequency: 7(base line, 1 month follow up, 3m, 6m,9m and 12m), 1 hr per patient. 
Comparator Agent  Standard care  Patients at control hospitals will be treated as per their treating physicians discretion. Duration of the study is 2 years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  PAROXYSMAL PERSISTENT OR PERMANENT ATRIAL FIBRILLATION WITH A 12 LEAD ECG SHOWING ATRIAL FIBRILLATION AND NOT DUE TO REVERSIBLE CAUSE LIKE POST CABG.
PATIENTS WITH AT LEAST TWO CHA2DS2VASc RISK FACTORS. 
 
ExclusionCriteria 
Details  MECHANICAL PROSTHETIC VALVE.
CLINICALLY UNSTABLE AT THE TIME OF ENROLLMENT(ie WITH ONGOING SHOCK).
TERMINAL ILLNESS AND/OR COMFORT CARE.
UNABLE TO PROVIDE CONSENT.
UNABLE TO HAVE ONE YEAR OF FOLLOW UP FOR AN REASON.
CLEAR AND ABSOLUTE CONTRAINDICATION TO ORAL COAGULATION (FOR EXAMPLE, ACTIVE BLEEDING OR RECENT LIFE THREATENING BLEEDING SUCH AS ICH).
ATRIAL FLUTTER
ENROLLMENT IN ANOTHER CLINICAL TRIAL
NO RECURRENCE OF ATRIAL FIBRILLATION AFTER ABLATION 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in proportion of patients taking oral anti coagulant from baseline to one year   Telephonic calls or patient visits at 1 month 3 month 6 month 9 month and 12 month. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in proportion of patients who continue anti coagulation for one year.
Change in proportion of patients who are not on anti coagulation at baseline and are on anti coagulation at one year.
Death (all cause and cardiovascular.
Stroke(hemorrhagic and non-hemorrhagic)
Major and non-major clinically relevant bleeding
 		 12 Months 
 
Target Sample Size   Total Sample Size="2800"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "2281"
Final Enrollment numbers achieved (India)="494" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/03/2015 
Date of Study Completion (India) 31/03/2017 
Date of First Enrollment (Global)  01/07/2014 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 A clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AF): design and rationale A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Prior observational studies such as the Rely-AF registry have demonstrated that the proportion of eligible patients with a diagnosis of atrial fibrillation receiving oral anticoagulation is sub-optimal. The registry also demonstrated poor levels of INR control, particularly in South Asian patients. IMPACT study aims to improve the proportion of eligible patients on oral anticoagulants and optimize oral anticoagulation in atrial fibrillation patients. We hypothesize that an educational intervention directed towards the physicians and patients will increase the proportion of eligible patients who are treated with oral anticoagulation and will further increase patient adherence and persistence to oral anticoagulation for 1 year. We propose to evaluate the intervention using a cluster randomized design, with the hospital being the unit of randomization. Physicians in the ’intervention’ clusters will receive the latest guidelines (ACC/AHA and NICE) on the management of atrial fibrillation and attend online webinars and live summits. At the patient level, patients will receive educational material on atrial fibrillation, its treatment and the importance of adhering to therapy. Furthermore, the patients will be followed up by trained non-physician health workers, who will facilitate regular follow-ups and improve communication between physicians and patients. We will recruit 600 patients and work with different  hospitals across India for the IMPACT study. Patients will be followed up for 1 year.
 
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