| 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
|
|
|
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
|
|
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.
|
|
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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. |