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
|
|
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
|
|
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. |