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

NCT ID: NCT04111289

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-01-28

Brief Summary

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

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..

Conditions

High Bolus Dose of Tirofiban

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

• 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

Patients did not receive upstream high bolus dose of tirofiban

Patient receive tirofiban downstream selectively according to operator discretion

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

• 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

Interventions

-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

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman Qaood Mohammed

Principel investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Qaood

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Doaa Ahmed Fouad, Professor

Role: CONTACT

fouaddoaa@yahoo.com

01001085828

Amr El Badry Ibrahim, Lectural

Role: CONTACT

Amr_el_badry@hotmail.com

01060701601

Other Identifiers

Tirofiban in STEMI patient

Identifier Type: -

Identifier Source: org_study_id