Suspended

TISPEffect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome

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What is being tested

-Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)

Drug
Who is being recruted

+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 2019
See protocol details

Summary

Principal SponsorAssiut University
Study ContactDoaa Ahmed Fouad, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2019

Actual date on which the first participant was enrolled.

* Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).1 PPCI restores thrombolysis in myocardial infarction flow 3 (TIMI 3) in over 90% of patients. However ,there remains a small proportion of patients, who continue to exhibit overt impairment of myocardial reperfusion despite successful opening of infarct related epicardiual artery (IRA). This phenomenon is called no-reflow, which is largely because of severe microvascular obstruction (MVO). * Belonging to the class of glycoprotein IIb/IIIa inhibitors (GPIs), tirofiban, can be useful in primary PCI for acute coronary syndrome (ACS).1,2The administration of tirofiban is an efficacious treatment option to reduce ischemic events in patients with The ACS and/or those undergoing PCI.2,3 In most guidelines, abciximab is recommended as the drug of first choice4 due to the finding that tirofiban is less effective than abciximab in platelet inhibition within 60 min of intravenous administration. However, some recent systemic reviews of randomized trials have not demonstrated obvious difference between smGPIs (eptifibatide or tirofiban) and abciximab in terms of angiographic, electrocardiographic, and clinical outcomes of patients undergoing primary PCI.5,6 Tirofiban may provide similar efficacy with an improved safety profile when compared with abciximab, particularly with a high-dose bolus regimen.7,8 In the new guideline, the recommended class of smGPIs has changed from IIb to IIa, but tirofiban remains with a pre-PCI indication of IIb, B.4 Although early treatment was associated with a significantly better TIMI flow and superior TIMI myocardial perfusion grades (TMPG) in some trials,9,10 no difference in clinical outcome was found between the 2 strategies in later study.11 One potential cost of administration of GPIs could be increased bleeding, although both major bleeding and minor bleeding rate are low in the tirofiban-treated patients..

Official TitleEffect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome
NCT04111289
Principal SponsorAssiut University
Study ContactDoaa Ahmed Fouad, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Acute STEMI patient within 12 hours of chest pain

10 exclusion criteria prevent from participating
Known CKD with Cr cl less than 60 ml/min

Uncontrolled HTN more than 180/110 mmHg

Suspected aortic dissection

previous infarction in the same infarct- related artery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
* After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion ) * Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) * Randomization will be performed by Microsoft Excel where random order will be generated for the study population

Group II

Active Comparator
Patient receive tirofiban downstream selectively according to operator discretion

Study Objectives

Primary Objectives

Study Centers

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