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

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ClinicalTrials.gov Identifier: NCT04111289
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Qaood Mohammed, Assiut University

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

Condition or disease Intervention/treatment Phase
High Bolus Dose of Tirofiban Drug: -Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion) Phase 1 Phase 2

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..

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Upstream High Bolus Dose of Tirofiban in Primary PCI for the Patients With STEMI on Short Term Outcome
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 28, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tirofiban

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




Primary Outcome Measures :
  1. Primary (main): [ Time Frame: 40 days ]
    Angiographic result (TIMI flow & MB) after PPCI.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111289


Contacts
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Contact: Doaa Ahmed Fouad, Professor 01001085828 fouaddoaa@yahoo.com
Contact: Amr El Badry Ibrahim, Lectural 01060701601 Amr_el_badry@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Eman Qaood Assiut University
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Responsible Party: Eman Qaood Mohammed, Principel investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04111289    
Other Study ID Numbers: Tirofiban in STEMI patient
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors