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

Acute ST Segment Elevation Myocardial Infarction Clinical Trial

— SEPCIT  

Official title:

Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03137212
• Other study ID #: SecondJilinU-2
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2017
• Last updated: April 30, 2017
• Start date: April 17, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2017
• Source: Second Hospital of Jilin University
• Contact: Bin Liu, Doctor
• Phone: 043188796598
• Email: liubin3333[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute ST Segment Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Combination Product:
• thrombolysis 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.
• thrombolysis 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.

Locations

Country	Name	City	State
China	The second hospital of Jilin university	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-PCI(percutaneous coronary intervention) myocardial perfusion (TIMI flow grade)	The investigators will check myocardial perfusion (TIMI flow grade) after PCI (percutaneous coronary intervention)immediately.	intraoperative
Primary	The incidence of no reflow	The investigators will check the incidence of no reflow after PCI(percutaneous coronary intervention) immediately.	intraoperative
Secondary	Major Adverse Cardiovascular Events (MACE)	Death and recurrence of myocardial infarction and target vessels revascularization	1 month, 3 month,6 month,12 month
Secondary	Post-PCI heart function	The value of ejection fraction will be examined by cardiac ultrasound for heart function.	1 month, 3 month,6 month,12 month
Secondary	The incidence of serious bleeding events	The incidence of serious bleeding events including all cause.	1 year