Myocardial Infarction Clinical Trial
— ERUPTIONOfficial title:
A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON
Verified date | August 2018 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.
Status | Completed |
Enrollment | 362 |
Est. completion date | September 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - ST-segment elevation AMI within 12 hours of symptom onset Exclusion Criteria: - Contraindications to thrombolysis or PCI - Patients administered a fibrinolytic agent before PCI - Patients enrolled in clinical trials |
Country | Name | City | State |
---|---|---|---|
China | Department of Cardiology, Zhongshan Hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | TIMI defined total major bleeding | 30 days post PCI | ||
Primary | Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC) | At the end of Percutaneous Coronary Intervention procedure | ||
Secondary | ST segment resolution in ECG | 3 hours post PCI procedure | ||
Secondary | peak troponin T level | in the 7 days post PCI procedure | ||
Secondary | plasma N terminal-proBNP levels | 1 and 30 days post PCI procedure | ||
Secondary | infarction area confirmed by SPECT | 30 days post PCI | ||
Secondary | incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization | 30 days post PCI |
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