Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time

Not Applicable

• Conditions: Acute ST Segment Elevation Myocardial Infarction
• Interventions: Combination Product: thrombolysis and PCI of B type; Combination Product: thrombolysis and PCI of A type

• Registration Number: NCT03137212
• Lead Sponsor: Second Hospital of Jilin University

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.

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-16
• Study Start: 2017-04-17
• Study First Submitted QC: 2017-04-30
• Last Update Submitted: 2017-04-30
• Study First Posted: 2017-05-02
• Last Update Posted: 2017-05-02
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B group	thrombolysis and PCI of B type	STEMI patients first are given thrombolysis and then transfer to PCI center to be treated by PCI 6-24 hours after thrombolysis if the thrombolysis is successful. if the thrombolysis is not successful, patients will be treated by PCI immediately.
A group	thrombolysis and PCI of A type	STEMI patients first are given thrombolysis and then transfer to PCI center to be treated by PCI 3-6 hours after thrombolysis if the thrombolysis is successful. if the thrombolysis is not successful, patients will be treated by PCI immediately.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Major Adverse Cardiovascular Events （MACE）	1 month, 3 month,6 month,12 month	Death and recurrence of myocardial infarction and target vessels revascularization
The incidence of serious bleeding events	1 year	The incidence of serious bleeding events including all cause.

Trial Locations

Locations (1)

The second hospital of Jilin university; 🇨🇳 Changchun, Jilin, China