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
Recruitment status was Recruiting
Sponsor:
Beijing Anzhen Hospital
Information provided by:
Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01181388
First received: August 11, 2010
Last updated: August 12, 2010
Last verified: June 2010
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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:
MedlinePlus related topics:
Heart Attack
Drug Information available for:
Tirofiban hydrochloride
U.S. FDA Resources
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
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 May 23, 2013