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 recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Beijing Anzhen Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01181388
First received: August 11, 2010
Last updated: August 12, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention
Myocardial Infarction
Procedure: administration of tirofiban by thrombus aspiration catheter in infarct-related artery
Procedure: administration of tirofiban by guide catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • Major adverse cardiovascular events [ Time Frame: 1 month after PCI ] [ Designated as safety issue: No ]
    Infarct size, reinfarction, motality, et.al.

  • Major adverse cardiovascular events [ Time Frame: 3 months after PCI ] [ Designated as safety issue: No ]
    Infarct size, reinfarction, motality, et.al.

  • Major Adverse Cardiovascular Events [ Time Frame: 6 months after PCI ] [ Designated as safety issue: No ]
    Infarct size, reinfarction, motality, et.al.


Secondary Outcome Measures:
  • number of participants with bleeding events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    bleeding events are assessed by Thrombolysis In Myocardial Infarction(TIMI) criteria


Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181388

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

Locations
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
  More Information

No publications provided

Responsible Party: Hongbing Yan, the 28th Division, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01181388     History of Changes
Other Study ID Numbers: 64456541
Study First Received: August 11, 2010
Last Updated: August 12, 2010
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hemorrhage
Infarction
Myocardial Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014