Effect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome (TISP)

The goal of the study to investigate the impact of upstream HBD of Tirofiban on short outcome of STEMI patient.

Study Overview

• Status: Unknown
• Conditions: High Bolus Dose of Tirofiban
• Intervention / Treatment: Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)

Detailed Description

• 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..

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amr El Badry Ibrahim, Lectural; Phone Number: 01060701601; Email: Amr_el_badry@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Acute STEMI patient within 12 hours of chest pain

Exclusion Criteria:

• -previous infarction in the same infarct- related artery
• ISR
• Resistent cardiogenic shock
• Known CKD with Cr cl less than 60 ml/min
• Uncontrolled HTN more than 180/110 mmHg
• Suspected aortic dissection
• Traumatic or prolonged CPR
• Severe trauma or major surgery within 3 month
• Active peptic ulcer within past 3 month
• Known history of coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Patient received upstream high bolus dose of tirofiban; 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	Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion); 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
ACTIVE_COMPARATOR: Patients did not receive upstream high bolus dose of tirofiban; Patient receive tirofiban downstream selectively according to operator discretion	Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary (main):	Angiographic result (TIMI flow & MB) after PPCI.	40 days

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Eman Qaood, Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): January 28, 2022

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban
• Other Study ID Numbers: Tirofiban in STEMI patient

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No