Clinical trial NCT03137212: Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time
Official title: Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute ST Segment Elevation Myocardial Infarction
Keywords: Percutaneous Coronary Intervention
STEMI
Thrombosis
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Post-PCI（percutaneous coronary intervention） myocardial perfusion (TIMI flow grade)
timeFrame: intraoperative
measure: The incidence of no reflow
timeFrame: intraoperative
Secondary outcomes:
measure: Major Adverse Cardiovascular Events （MACE）
timeFrame: 1 month, 3 month,6 month,12 month
measure: Post-PCI heart function
timeFrame: 1 month, 3 month,6 month,12 month
measure: The incidence of serious bleeding events
timeFrame: 1 year
Other outcomes:
Locations:
city: Changchun
country: China
facility: The second hospital of Jilin university
state: Jilin
Study officials:
affiliation: Second Hospital of Jilin University
name: Bin Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: