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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01181388
Recruitment Status : Unknown
Verified June 2010 by Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : August 13, 2010
Last Update Posted : August 13, 2010
Sponsor:
Information provided by:
Beijing Anzhen Hospital

Brief Summary:
Superselective IRA infusion of tirofiban may improve myocardial reperfusion and reduce bleeding complications in AMI patients.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: administration of tirofiban by thrombus aspiration catheter in infarct-related artery Procedure: administration of tirofiban by guide catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tirofiban

Arm Intervention/treatment
Active Comparator: intra-guide-catheter infusion of tirofiban Procedure: administration of tirofiban by guide catheter
a bolus of 10ug/kg tirofiban administration via guide catheter followed by 0.1ug/kg/min for 12 hours after PCI

Experimental: intra-thrombus-aspiration-catheter infusion of tirofiban Procedure: administration of tirofiban by thrombus aspiration catheter in infarct-related artery
a bolus of 10ug/kg tirofiban administration via thrombus aspiration catheter followed by 0.1ug/kg/min for 12 hours after PCI




Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 1 month after PCI ]
    Infarct size, reinfarction, motality, et.al.

  2. Major adverse cardiovascular events [ Time Frame: 3 months after PCI ]
    Infarct size, reinfarction, motality, et.al.

  3. Major Adverse Cardiovascular Events [ Time Frame: 6 months after PCI ]
    Infarct size, reinfarction, motality, et.al.


Secondary Outcome Measures :
  1. number of participants with bleeding events [ Time Frame: 1 month ]
    bleeding events are assessed by Thrombolysis In Myocardial Infarction(TIMI) criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01181388


Contacts
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Contact: Shaoping Wang, MD, PhD +861064456995 wang_shaoping@hotmail.com
Contact: Yunpeng Chi, MD +861064456541 chiyunpeng0711@sohu.com

Locations
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China, Beijing
the 28th division, Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Shaoping Shaoping, MD. PhD    +861064456995    wang_shaoping@hotmail.com   
Contact: Yunpeng Chi, MD    +861064456541    chiyunpeng0711@sohu.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
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Responsible Party: Hongbing Yan, the 28th Division, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01181388    
Other Study ID Numbers: 64456541
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: August 13, 2010
Last Verified: June 2010
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors