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CTRI Number  CTRI/2018/10/015937 [Registered on: 08/10/2018] Trial Registered Prospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   The effect of intracoronary nicorandil in improving coronary blood flow during primary angioplasty  
Scientific Title of Study   The efficacy of intracoronary Nicorandil prior to stenting in prevention of no-reflow/ slow-reflow phenomenon during primary angioplasty  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreejith A G 
Designation  Senior resident 
Affiliation  kearala university of health sciences 
Address  Department of Cardiology,government medical college kozhikode

Kozhikode
KERALA
673008
India 
Phone    
Fax    
Email  agsreejith@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinayakumar D 
Designation  Associate Professor 
Affiliation  kearala university of health sciences 
Address  Department of Cardiology,government medical college kozhikode

Kozhikode
KERALA
673008
India 
Phone  9847015011  
Fax    
Email  vinayakumard@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sreejith A G 
Designation  Senior resident 
Affiliation  kearala university of health sciences 
Address  Department of Cardiology,government medical college kozhikode

Kozhikode
KERALA
673008
India 
Phone    
Fax    
Email  agsreejith@gmail.com  
 
Source of Monetary or Material Support  
Government medical college kozhikode 
 
Primary Sponsor  
Name  Dr Sreejith A G 
Address  Dr Sreejith A G, senior resident,government medical college kozhikode 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr sreejith A G  government medical college kozhikode  department of cardiology,government medical college,medical college road kozhikode.
Kozhikode
KERALA 
9495385255

agsreejith@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt medical College Kozhikode4th Floor Golden Jubilee Annex Insitute of Maternal and Child health Calicut-673008 Kerala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, (2) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  randomised control trial  Subjects in the Nicorandil Group will be then given 2 mg intracoronary nicorandil prior to stent implantation. In the Control Group, conventional primaryPCI will be performed without nicorandil administration.  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  90.00 Day(s)
Gender  Both 
Details  Patients undergoing primary PCI  
 
ExclusionCriteria 
Details  patients with cardiogenic shock; severe liver, renal, or brain dysfunction; or other serious complications at the time of admission were excluded. Those who had taken nicorandil prior to admission w also excluded 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in TIMI flow grade  improvement in TIMI flow grade after balloon dilatation before stenting 
 
Secondary Outcome  
Outcome  TimePoints 
nil  NA 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/10/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  
The no-reflow phenomenon is characterized by inadequate myocardial perfusion without angiographic manifestations of mechanical vascular occlusion. The phenomenon occurs after coronary vascular interventions. The development of the no-reflow phenomenon significantly worsens clinical evolution of disease increasing the number of cases of congestive heart failure and hospital mortality. Changes of endothelial function and morphology, changes of blood rheology and microvascular autoregulation are important for pathogenesis of the phenomenon. 
              Pharmacological drug management has been the sheet anchor of modern therapy utilized  in the cath lab to manage no reflow in acute setting. The treatment include intracoronary introduction of verapamil, adenosine, intravenous introduction of activators of KATP channels (nicorandil), inhibitors of glycoprotein IIb/IIIa receptors. Drugs are administered by intracoronary route and delivered directly into the IRA by guiding catheter or through infusion catheters, since the drugs given intravenously may not reach the target site due to microvascular obstruction in no reflow. Intravenous nicorandil infusion with percutaneous coronary intervention (PCI) has been reported to reduce reperfusion injury events and improve cardiac function in patients with acute myocardial infarction (MI). However, there is limited information on the use of intracoronary nicorandil.
               This study is designed to determine the change in no-reflow, slow flow,when intracoronary nicorandil was administered to patients with ASTEMI undergoing primary PCI.
OBJECTIVES:To find out improvement in thrombolysis in myocardial infarction (TIMI) flow  grade after PCI in subjects treated with intracoronary nicorandil compared to controls.
 
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