Tirofiban Intracoronary Bolus-only Versus Intravenous Bolus Plus Infusion in STEMI Patients
Prospective Randomized Controlled Clinical Study to Compare Tirofiban Intracoronary Bolus-Only vs Intravenous Bolus Plus Infusion in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
1 other identifier
interventional
49
0 countries
N/A
Brief Summary
The aim of this randomized trial is to compare the efficacy of high dose tirofiban administered as either an intracoronary bolus alone or as an intravenous bolus followed by a maintenance infusion with respect to microvascular perfusion and long term left ventricular infarct size, volumes and function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2008
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
April 22, 2010
CompletedApril 22, 2010
March 1, 2010
5 months
April 21, 2010
April 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Indices of microvascular perfusion
Intracoronary hemodynamic measures of index of microvascular resistance and coronary flow reserve
Post-PCI day 4 to 5
Secondary Outcomes (6)
ST segment resolution
post-PCI 90. minute
corrected TIMI frame count
immediately after PCI, post-PCI day 4 to 5
Myocardial Blush Grade
immediately after PCI, post-PCI day 4 to 5
Scintigraphic infarct size
6th month
Changes in left ventricular volume
Post-PCI day 3- 6th month
- +1 more secondary outcomes
Study Arms (2)
Tirofiban intracoronary bolus-only
EXPERIMENTALTirofiban bolus administered via intracoronary route at the time of primary PCI with no additional peri/postprocedural maintenance infusion
Tirofiban intravenous bolus+infusion
ACTIVE COMPARATORTirofiban bolus administered intravenously before PCI, followed by periprocedural maintenance infusion
Interventions
administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
Eligibility Criteria
You may qualify if:
- Typical ongoing ischemic chest pain for longer than 30 minutes
- ST segment elevation of 0,1 mV or greater in at least two contiguous leads or a new left bundle branch block on the initial ECG.
You may not qualify if:
- Cardiogenic shock and / or clinical instability
- previous STEMI
- Malignant life threatening diseases
- Presence of an additional lesion causing more than 50% narrowing distal to the culprit lesion
- Contraindications to aspirin, clopidogrel, or heparin
- inability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kosuyolu Heart Hospitallead
- The Society of Cardiac Health Protectioncollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cevat Kırma, Assoc.Prof
Kosuyolu Heart and Research Hospital
- PRINCIPAL INVESTIGATOR
Ayhan Erkol, M.D
Kosuyolu Heart and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 21, 2010
First Posted
April 22, 2010
Study Start
September 1, 2008
Primary Completion
February 1, 2009
Study Completion
August 1, 2009
Last Updated
April 22, 2010
Record last verified: 2010-03