Impacts of Superselective Infarct-related Artery (IRA) Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in Acute Myocardial Infarction (AMI) Patients (SUIT-AMI)
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
administration of tirofiban by thrombus aspiration catheter in infarct-related artery
administration of tirofiban by guide catheter
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- STEMI patients
- chest pain for less than 12hr
- plan to PCI
Exclusion Criteria:
- LM lesion
- stent thrombosis
- cardiac shock
- thrombocytopenia
- allergy to asprin
Sites / Locations
- the 28th division, Beijing Anzhen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
intra-guide-catheter infusion of tirofiban
intra-thrombus-aspiration-catheter infusion of tirofiban
Arm Description
Outcomes
Primary Outcome Measures
Major adverse cardiovascular events
Infarct size, reinfarction, motality, et.al.
Major adverse cardiovascular events
Infarct size, reinfarction, motality, et.al.
Major Adverse Cardiovascular Events
Infarct size, reinfarction, motality, et.al.
Secondary Outcome Measures
number of participants with bleeding events
bleeding events are assessed by Thrombolysis In Myocardial Infarction(TIMI) criteria
Full Information
NCT ID
NCT01181388
First Posted
August 11, 2010
Last Updated
August 12, 2010
Sponsor
Beijing Anzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01181388
Brief Title
Impacts of Superselective Infarct-related Artery (IRA) Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in Acute Myocardial Infarction (AMI) Patients
Acronym
SUIT-AMI
Official Title
Impacts of Superselective Infarct-related Artery Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in ST Segment Elevation Myocardial Infarction (STEMI) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
5. Study Description
Brief Summary
Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intra-guide-catheter infusion of tirofiban
Arm Type
Active Comparator
Arm Title
intra-thrombus-aspiration-catheter infusion of tirofiban
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
administration of tirofiban by thrombus aspiration catheter in infarct-related artery
Intervention Description
a bolus of 10ug/kg tirofiban administration via thrombus aspiration catheter followed by 0.1ug/kg/min for 12 hours after PCI
Intervention Type
Procedure
Intervention Name(s)
administration of tirofiban by guide catheter
Intervention Description
a bolus of 10ug/kg tirofiban administration via guide catheter followed by 0.1ug/kg/min for 12 hours after PCI
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events
Description
Infarct size, reinfarction, motality, et.al.
Time Frame
1 month after PCI
Title
Major adverse cardiovascular events
Description
Infarct size, reinfarction, motality, et.al.
Time Frame
3 months after PCI
Title
Major Adverse Cardiovascular Events
Description
Infarct size, reinfarction, motality, et.al.
Time Frame
6 months after PCI
Secondary Outcome Measure Information:
Title
number of participants with bleeding events
Description
bleeding events are assessed by Thrombolysis In Myocardial Infarction(TIMI) criteria
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
STEMI patients
chest pain for less than 12hr
plan to PCI
Exclusion Criteria:
LM lesion
stent thrombosis
cardiac shock
thrombocytopenia
allergy to asprin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoping Wang, MD, PhD
Phone
+861064456995
Email
wang_shaoping@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Chi, MD
Phone
+861064456541
Email
chiyunpeng0711@sohu.com
Facility Information:
Facility Name
the 28th division, Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoping Shaoping, MD. PhD
Phone
+861064456995
Email
wang_shaoping@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yunpeng Chi, MD
Phone
+861064456541
Email
chiyunpeng0711@sohu.com
12. IPD Sharing Statement
Learn more about this trial
Impacts of Superselective Infarct-related Artery (IRA) Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in Acute Myocardial Infarction (AMI) Patients
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