Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time
SEPCIT
Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2017
CompletedStudy Start
First participant enrolled
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedMay 2, 2017
April 1, 2017
3 years
April 16, 2017
April 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
The incidence of no reflow
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
intraoperative
Secondary Outcomes (3)
Major Adverse Cardiovascular Events （MACE）
1 month, 3 month,6 month,12 month
Post-PCI heart function
1 month, 3 month,6 month,12 month
The incidence of serious bleeding events
1 year
Study Arms (2)
A group
EXPERIMENTALSTEMI 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.
B group
EXPERIMENTALSTEMI 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.
Interventions
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.
Eligibility Criteria
You may qualify if:
- Aged 19 to 70 years old, gender not limited
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second hospital of Jilin university
Changchun, Jilin, 130041, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bin Liu, Doctor
Second Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2017
First Posted
May 2, 2017
Study Start
April 17, 2017
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
May 2, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share
when the investigators complete the study and publish our data