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

April 30, 2017 updated by: Second Hospital of Jilin University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yongfeng Shi, Doctor
  • Phone Number: 043188796625
  • Email: 32919079@qq.com

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130041
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group
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.
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.
Experimental: B group
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.
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative
The incidence of no reflow
Time Frame: intraoperative
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events （MACE）
Time Frame: 1 month, 3 month,6 month,12 month
Death and recurrence of myocardial infarction and target vessels revascularization
1 month, 3 month,6 month,12 month
Post-PCI heart function
Time Frame: 1 month, 3 month,6 month,12 month
The value of ejection fraction will be examined by cardiac ultrasound for heart function.
1 month, 3 month,6 month,12 month
The incidence of serious bleeding events
Time Frame: 1 year
The incidence of serious bleeding events including all cause.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2017

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 30, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2017

Last Update Submitted That Met QC Criteria

April 30, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SecondJilinU-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

when the investigators complete the study and publish our data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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