| CTRI Number |
CTRI/2026/02/103052 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Heart Medicines (Tirofiban and Nitroglycerin) to Improve Small Blood Vessel Blood Flow in Heart Attack Patients Undergoing Emergency Angioplasty |
|
Scientific Title of Study
|
Comparative effect of Intracoronary
Tirofiban versus Nitroglycerin on Index of Microcirculatory Resistance in patients undergoing primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepanshu |
| Designation |
DM Resident |
| Affiliation |
Govt. Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Cardiology, Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9958304977 |
| Fax |
|
| Email |
ydeepanshu997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeet Ram Kashyap |
| Designation |
Professor and Head of Department |
| Affiliation |
Govt. Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Cardiology, Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
6283643929 |
| Fax |
|
| Email |
jeetramkashyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepanshu |
| Designation |
DM Resident |
| Affiliation |
Govt. Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Cardiology, Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9958304977 |
| Fax |
|
| Email |
ydeepanshu997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Medical College and Hospital,Sector-32,Chandigarh,India, Pin-160030 |
|
|
Primary Sponsor
|
| Name |
Govt Medical College and Hospital Chandigarh |
| Address |
Department of Cardiology, Govt. Medical College and Hospital, Sector 32, Chandigarh, India, Pin-160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Deepanshu |
Govt. Medical College and Hospital Chandigarh |
Department of Cardiology, Govt. Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9958304977
ydeepanshu997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intracoronary Nitroglycerine |
70 STEMI patients over a duration of 18 months with IMR more than 31 after PCI will be divided into two groups after randomization. Group 2 will receive stat Intracoronary Nitroglycerine, and then a reduction in IMR will be measured. |
| Intervention |
Intracoronary Tirofiban |
70 STEMI patients over a duration of 18 months with IMR more than 31 after PCI will be divided into two groups after randomization. Group 1 will receive stat Intracoronary Tirofiban, and then a reduction in IMR will be measured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult men and women aged over 18 yr and less than 75 yr who present with STEMI within
12 hours of symptom onset and are hemodynamically stable. Patients will be eligible if
they have symptoms consistent with myocardial ischemia (chest pain, dyspnea) for at least
20 minutes accompanied by definite ECG changes indicating STEMI as defined by
ACC/AHA guidelines.
2. Successful reperfusion of infarct-related artery with restoration of epicardial flow.
3. Willing and able to comply with all study requirements, including treatment, assessment,
and clinic visit attendances. |
|
| ExclusionCriteria |
| Details |
1. Previous MI/PCI/coronary bypass grafting (CABG) in the culprit vessel.
2. Other distal residual lesions with more than 50 percent diameter stenosis in the culprit vessel.
3. Presence of contraindications to study drugs.
4. Presence of contraindications to adenosine infusion for IMR measurement, including sinus
node disease, moderate to severe bronchospastic disease, and second or third-degree
atrioventricular (AV) block
5. Active malignancy
6. Concurrent illness, including severe infection that may jeopardize the ability of the patient
to undergo the procedures outlined in this protocol, with reasonable safety
7. Serious medical or psychiatric conditions
8. Pregnancy or lactation
(At time of PCI)
9. Patients who received GpIIb/IIIa treatment prior to IMR measurement.
10. Patients who do not undergo primary PCI due to the lack of severity of the culprit lesion or
other reasons, like cardiogenic shock requiring mechanical circulatory support. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in IMR after Intracoronary Tirofiban versus
Intracoronary Nitroglycerin among patients with IMR
more than 31 |
At baseline, 5 minutes after intracoronary drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To correlate IVUS lesion morphology with IMR
and angiographic slow-flow/no-reflow in STEMI
patients undergoing Primary PCI to study predictors
of MVO.
2. To correlate IMR with TIMI flow, Myocardial
blush grade (MBG), & ST-segment resolution 2
hours post PCI
3. To evaluate in-hospital & short-term clinical
outcomes at 30 days (Major Adverse
Cardiovascular Events & change in Left Ventricle
Ejection Fraction) |
IVUS will be done before stenting.
TIMI flow & Myocardial Blush Grade will be done during the index procedure.
ECG will be done 2 hours after PCI.
Clinical outcomes (MACE & 2D-ECHO) will be assessed in the hospital & at 30 days
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary purpose of this study is to compare the effectiveness of two different intracoronary medications—Tirofiban (a glycoprotein IIb/IIIa inhibitor) and Nitroglycerin (a vasodilator)—in treating Microvascular Obstruction (MVO) in patients who have undergone successful primary Percutaneous Coronary Intervention (PCI) for a STEMI (heart attack).While PCI restores blood flow in the large "epicardial" arteries, the small "microvascular" vessels often remain blocked, leading to worse patient outcomes. This study uses the Index of Microcirculatory Resistance (IMR), an invasive real-time measurement, to quantify this obstruction and determine which drug better improves microvascular blood flow. Additionally, the study seeks to use Intravascular Ultrasound (IVUS) to identify specific plaque characteristics that might predict which patients are at high risk for developing MVO. The study operates under the primary hypothesis that intracoronary Tirofiban will be more effective than intracoronary Nitroglycerin in reducing the Index of Microcirculatory Resistance (IMR) in STEMI patients who exhibit significant microvascular dysfunction (defined as an IMR >31 units) following successful reopening of the main blocked artery. |