Intracoronary Tirofiban on No-Reflow Phenomena
Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
1 other identifier
interventional
162
1 country
1
Brief Summary
The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2011
Typical duration for phase_4
1 active site
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
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 30, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedFebruary 4, 2014
February 1, 2014
2.9 years
January 30, 2014
February 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
in-hospital mortality
up to 8 days
Non-fatal myocardial infarction
up to 8 days
in-stent thrombosis
up to 8 days
Study Arms (2)
Tirofiban group
ACTIVE COMPARATORIf thrombolysis in myocardial infarction flow \<3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary tirofiban (25 µgr/kg) was administered via the guiding catheter to the infarct related artery
Placebo group
PLACEBO COMPARATORIf thrombolysis in myocardial infarction flow \<3 in spite of performed treatments, patients were considered as no-reflow and randomized to tirofiban or placebo group. Intracoronary serum physiologic as placebo was administered via the guiding catheter to the infarct related artery
Interventions
Eligibility Criteria
You may qualify if:
- \- Patients with ST-elevated myocardial infarction who developed no-reflow phenomena
You may not qualify if:
- Treatment with thrombolytic drugs in the previous 24 hours
- Known malignancy
- Pain to balloon time \>6 hours
- Uncontrolled hypertension (\>180/110 mmHg)
- Bleeding diathesis
- Thrombocytopenia
- End-stage liver disease
- Cardiogenic shock
- Renal failure
- Life expectancy of less than 1 year
- Contraindication for the use of tirofiban.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University School of Medicine
Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor of Cardiology department
Study Record Dates
First Submitted
January 30, 2014
First Posted
February 4, 2014
Study Start
January 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 4, 2014
Record last verified: 2014-02