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CTRI Number  CTRI/2017/09/009796 [Registered on: 15/09/2017] Trial Registered Retrospectively
Last Modified On: 07/04/2017
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   This study is being conducted to evaluate the safety and efficacy of a strategy of early fibrinolytic treatment with Reteplase (rPA) in patients with ST- segment elevation myocardial infarction (STEMI). 
Scientific Title of Study   A prospective, observational, study of Pharmaco-invasive Strategy with Reteplase in Indian patients with STEMI - RePAMI 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thomas Alexander 
Designation  Consultant and Interventional Cardiologist 
Affiliation  Kovai Medical Center and Hospital Ltd 
Address  R.No:123,Department of Cardiology, Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore.Tamilnadu,India
R.No:123,Department of Cardiology, Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore.Tamilnadu,India
Coimbatore
TAMIL NADU
641014
India 
Phone  9791907685  
Fax  0422-2627782  
Email  tomalex41@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Thomas Alexander 
Designation  Consultant and Interventional Cardiologist 
Affiliation  Kovai Medical Center and Hospital Ltd 
Address  R.No:123,Department of Cardiology, Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore.Tamilnadu,India
R.No:123,Department of Cardiology, Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore.Tamilnadu,India
Coimbatore
TAMIL NADU
641014
India 
Phone  9791907685  
Fax  0422-2627782  
Email  tomalex41@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thomas Alexander 
Designation  Consultant and Interventional Cardiologist 
Affiliation  Kovai Medical Center and Hospital Ltd 
Address  R.No:123,Department of Cardiology, Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore.Tamilnadu,India
R.No:123,Department of Cardiology, Kovai Medical Center and Hospital P.B.No.:3209,Avinashi road Coimbatore.Tamilnadu,India
Coimbatore
TAMIL NADU
641014
India 
Phone  9791907685  
Fax  0422-2627782  
Email  tomalex41@gmail.com  
 
Source of Monetary or Material Support  
STEMI INDIA CHARITABLE TRUST, Site No 204-205,Avinashi Road, Gold Wins,Poongothi nagar,Kallapatti post,Coimbatore-641014 Tamilnadu 
 
Primary Sponsor  
Name  STEMI INDIA  
Address  #204-205, Poongothai Nagar, Civil Aerodrome P.O, Coimbatore - 641 014.Tamilnadu,India  
Type of Sponsor  Other [ Trust] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vimal Abraham  Christian Fellowship Hospital  Consultant, Department of Medicine, Oddanchathiram -624619
Dindigul
TAMIL NADU 
9597301704

Vimalabraham29@gmail.com 
Thomas Alexander  Kovai Medical Center and Hospital  Room No:123,Department of Cardiology, P.B.No.:3209,Avinashi road Coimbatore-641014, India
Coimbatore
TAMIL NADU 
9791907685
04222627782
tomalex41@gmail.com 
Ramakrishnan S  Pollachi Cardiac Center   Tamilmani Nagar, Kovai road, Pollachi-642001
Coimbatore
TAMIL NADU 
9363103931

pccpollachi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kovai Medical Centre and Hospital  Approved 
Institutional Ethics Committee, Kovai Medical Centre and Hospital  Approved 
Institutional Ethics Committee, Kovai Medical Centre and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  STEMI,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Thrombolysis and PCI   This is a pilot, prospective, observational, study to evaluate the efficacy and safety of a strategy of early fibrinolytic treatment with Reteplase (rPA) and additional antiplatelet and antithrombin therapy followed by catheterization within 3-24 hours with timely coronary intervention as appropriate (or by Rescue Coronary Intervention if required) in patients with ST-elevation Myocardial Infarction (STEMI) within 12 hours of symptom onset. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Adults 18 to 75 years of age complaining of chest pain, discomfort and/or indications of STEMI requiring either primary PCI or pharmaco-invasive treatment with Reteplace will be included in the study.
2.Patients presenting with the onset of symptoms within 12 hours.
3.ST elevation New ST elevation at the J point in two contiguous leads with the cut-points: > 0.1 mV in all leads other than leads V2–V3 where the following cut points apply: > 0.2 mV in men > 40 years; > 0.25 mV in men < 40 years, or > 0.15 mV in women.
4.Subjects / LAR or impartial witness (if applicable) must be able to understand and provide their consent in the informed consent form
 
 
ExclusionCriteria 
Details  1.Previous enrollment in this study or treatment with the investigational drug or participating in any other study in the past 30 days
2.Patients who are unwilling to participate in the study or sign the informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of prompt fibrinolysis with rPA coupled with contemporary antiplatelet and antithrombotic therapy at first medical contact followed by timely catheterization or rescue coronary intervention in STEMI patients within 12 hours of symptom onset by IRA patency.   Angiographic patency of Infarct related artery (IRA)  
 
Secondary Outcome  
Outcome  TimePoints 
To assess safety during the course of the study by means of monitoring treatment emergent adverse events  1.Death, Reinfarction, repeat revascularization
2.Failed thrombolysis/rescue PCI
3.Nonintracranial hemorrhage (total, major, minor and blood transfusions)
4.Intracranial hemorrhage
5.Others
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   15/09/2016 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Acute coronary  syndrome is one of the leading causes of morbidity in India. Indians also show higher incidence of hospitalisation, morbidity, and mortality than other ethnic groups1.Current strategies of thrombolysis and PCI are well established interventions that are generally viewed as alternative approaches to restore coronary circulation.Standard primary PCI is superior to lytic therapy, provided it can be performed shortly after the first medical contact and by an experienced team. The ideal scenario of pre-hospital management of a patient with symptoms compatible with STEMI is as follows:

           Ambulance called

         Diagnosis made

        Catheterization laboratory at PCI-capable facility notified

Unfortunately, in many parts of the world, patients are taken by ambulance or by private transportation- to a non-PCI-capable center. In those cases, inter-hospital transfer to a PCI-capable center is desirable, provided that PCI can be performed within 90-120 minutes after the first medical contact. Importantly, the PCI-capable center should be open 24 hours a day, 7 days a week.

Real world data also suggests that the door to balloon time to begin PCI as suggested by guidelines is exceeded manifold in India (300 minutes versus 140-170 minutes) compared to the developed world. The reasons for reaching the hospital late can be attributed to socioeconomic status, lack of awareness about the symptoms, presence of different types of health care providers who prevent immediate access to tertiary care centres, lack of ambulance services, traffic congestion, long distances and consultations with family physicians.

Depending on the local circumstances, either immediate thrombolysis or rapid transfer to an experienced tertiary care centre is preferred. Pharmacoinvasive recanalisation is particularly attractive in Indian context and may ultimately benefit the patients.

When treating patients with STEMI, the time from onset of symptoms to reperfusion is crucial for salvaging myocardium. Recent data clearly demonstrates that time to reperfusion is positively associated with infarct size, edema, and micro vascular obstruction, and inversely associated with the degree of myocardial salvage, as determined by cardiac magnetic resonance imaging of STEMI patients after successful PCI. Indeed, the amount of myocardium salvaged drops markedly when the reperfusion time exceeds 90 minutes2.

This prospective, observational study aims at assessing the efficacy and safety of a strategy of early fibrinolytic treatment with Reteplase (rPA) and additional antiplatelet and antithrombin therapy followed by catheterization within 3-24 hours or Rescue Coronary Intervention in patients with STEMI within 12 hours of onset of symptoms. 

Primary PCI in Acute Myocardial Infarction is a preferred mode of revascularization as compared to thrombolytic therapy.  There is no primary data on rPA facilitated PCI. In Indian context TNK or rPA facilitated PCI (Pharmacoinvasive therapy) is a more practical solution.  This study aims to confirm the efficacy and safety of Pharmacoinvasive therapy in 200 patients with rPA.

 
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