Acute ST Segment Elevation Myocardial Infarction
Conditions
Keywords
Percutaneous Coronary Intervention, STEMI, Thrombosis
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.
Interventions
COMBINATION_PRODUCTthrombolysis and PCI of A type
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.
COMBINATION_PRODUCTthrombolysis and PCI of B type
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.
Sponsors
Second Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patients with STEMI will be divided into two group randomly. Patients of A group will be treated by thrombolysis and then 3-6 hours will be treated by PCI. Patients of B group will be treated by thrombolysis and then 6-24 hours will be treated by PCI.
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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 * Uncontrolled hypertension, systolic blood pressure before thrombolysis is still 160 mmHg or higher, diastolic blood pressure is still 100 mmHg or higher * Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks * Severe liver and kidney dysfunction * Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm * Thrombolysis treatment in one week * Allergies of thrombolysis drug or contrast * Participated in any clinical trials within three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of no reflow | 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) | intraoperative | The investigators will check myocardial perfusion (TIMI flow grade) after PCI （percutaneous coronary intervention）immediately. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events （MACE） | 1 month, 3 month,6 month,12 month | Death and recurrence of myocardial infarction and target vessels revascularization |
| Post-PCI heart function | 1 month, 3 month,6 month,12 month | The value of ejection fraction will be examined by cardiac ultrasound for heart function. |
| The incidence of serious bleeding events | 1 year | The incidence of serious bleeding events including all cause. |
Countries
China
Contacts
Primary ContactBin Liu, Doctor
Backup ContactYongfeng Shi, Doctor
Outcome results
None listed