Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute ST Segment Elevation Myocardial Infarction
- Sponsor
- Second Hospital of Jilin University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The incidence of no reflow
- Last Updated
- 9 years ago
Overview
Brief Summary
Patients with acute ST-segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.
Detailed Description
The noninferiority multicenter, prospective, randomized, controlled study of urokinase of restructuring the original design evaluation (rhPro - UK) at different times after thrombolysis combined with percutaneous coronary intervention（PCI）therapy of acute ST segment elevation myocardial infarction.Patients with acute ST segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 19 to 70 years old, gender not limited
- •30 minutes or more persistent ischemia chest pain, and symptoms can't ease by treated by nitroglycerin
- •In two or more lead ecg ST-segment（the line between QRS complex finish point and the start point of T wave in electrocardiogram) elevation ≥ 0.1mv, or two or more than two neighboring chest lead ST-elevation ≥0.2mv
- •Persistent ischemia chest pain less than 6 hours, door to balloon time\>90 minutes and transfer time \>120 minutes
- •Accept coronary arteriography and intervention treatment
- •Signed informed consent
Exclusion Criteria
- •Pregnancy and lactation, menstrual period women
- •Blood disease, clotting hemorrhagic disease, any part of active bleeding or bleeding tendency physique
- •History of trauma in two months, including biopsy and received surgical operation
- •History of the great vessels punctured in two weeks that could not oppression
- •History of ischemic or hemorrhagic stroke and cerebrovascular accident
- •Cardiac shock,reinfarction again, right ventricular myocardial infarction, history of cardiopulmonary resuscitation (CPR)
- •History of PCI or coronary artery bypass grafting（CABG）
- •Killip classification level III（a standard of heart function classification） or above, or cardiac mechanical complications such as cardiac rupture
- •History of eyeground hemorrhage
- •Currently use of therapeutic doses of anticoagulants, such as warfarin, etc
Outcomes
Primary Outcomes
The incidence of no reflow
Time Frame: intraoperative
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
Post-PCI（percutaneous coronary intervention） myocardial perfusion (TIMI flow grade)
Time Frame: intraoperative
The investigators will check myocardial perfusion (TIMI flow grade) after PCI （percutaneous coronary intervention）immediately.
Secondary Outcomes
- Post-PCI heart function(1 month, 3 month,6 month,12 month)
- Major Adverse Cardiovascular Events （MACE）(1 month, 3 month,6 month,12 month)
- The incidence of serious bleeding events(1 year)