Impacts of Superselective Infarct-related Artery (IRA) Infusion of Tirofiban on Myocardial Reperfusion and Bleeding Complications in Acute Myocardial Infarction (AMI) Patients

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01181388
• Other study ID #: 64456541
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2010
• Last updated: August 12, 2010
• Start date: April 2010
• Est. completion date: October 2012

Study information

• Verified date: June 2010
• Source: Beijing Anzhen Hospital
• Contact: Shaoping Wang, MD, PhD
• Phone: +861064456995
• Email: wang_shaoping[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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
• 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

Locations

Country	Name	City	State
China	the 28th division, Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	Infarct size, reinfarction, motality, et.al.	1 month after PCI	No
Primary	Major adverse cardiovascular events	Infarct size, reinfarction, motality, et.al.	3 months after PCI	No
Primary	Major Adverse Cardiovascular Events	Infarct size, reinfarction, motality, et.al.	6 months after PCI	No
Secondary	number of participants with bleeding events	bleeding events are assessed by Thrombolysis In Myocardial Infarction(TIMI) criteria	1 month	Yes