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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
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 11, 2010
Last Updated
August 12, 2010
Sponsor
Beijing Anzhen Hospital
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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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