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

Primary Purpose

Acute ST Segment Elevation Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
thrombolysis and PCI of A type
thrombolysis and PCI of B type
Sponsored by
Second Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST Segment Elevation Myocardial Infarction focused on measuring Percutaneous Coronary Intervention, STEMI, Thrombosis

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The second hospital of Jilin universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A group

B group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
The incidence of no reflow
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.

Secondary Outcome Measures

Major Adverse Cardiovascular Events （MACE）
Death and recurrence of myocardial infarction and target vessels revascularization
Post-PCI heart function
The value of ejection fraction will be examined by cardiac ultrasound for heart function.
The incidence of serious bleeding events
The incidence of serious bleeding events including all cause.

Full Information

First Posted
April 16, 2017
Last Updated
April 30, 2017
Sponsor
Second Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT03137212
Brief Title
Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time
Acronym
SEPCIT
Official Title
Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Hospital of Jilin University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST Segment Elevation Myocardial Infarction
Keywords
Percutaneous Coronary Intervention, STEMI, Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group
Arm Type
Experimental
Arm Description
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.
Arm Title
B group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
thrombolysis and PCI of A type
Intervention Description
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.
Intervention Type
Combination Product
Intervention Name(s)
thrombolysis and PCI of B type
Intervention Description
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.
Primary Outcome Measure Information:
Title
Post-PCI（percutaneous coronary intervention） myocardial perfusion (TIMI flow grade)
Description
The investigators will check myocardial perfusion (TIMI flow grade) after PCI （percutaneous coronary intervention）immediately.
Time Frame
intraoperative
Title
The incidence of no reflow
Description
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events （MACE）
Description
Death and recurrence of myocardial infarction and target vessels revascularization
Time Frame
1 month, 3 month,6 month,12 month
Title
Post-PCI heart function
Description
The value of ejection fraction will be examined by cardiac ultrasound for heart function.
Time Frame
1 month, 3 month,6 month,12 month
Title
The incidence of serious bleeding events
Description
The incidence of serious bleeding events including all cause.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Liu, Doctor
Phone
043188796598
Email
liubin3333@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongfeng Shi, Doctor
Phone
043188796625
Email
32919079@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Liu, Doctor
Organizational Affiliation
Second Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second hospital of Jilin university
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Wang, Doctor
Phone
043188796625
Email
wanghe221@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
when the investigators complete the study and publish our data

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

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