Acute ST Segment Elevation Myocardial InfarctionSEPCITNCT03137212
Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time
A study testing thrombolysis and PCI of A type and thrombolysis and PCI of B type in people with Acute ST Segment Elevation Myocardial Infarction, run by Second Hospital of Jilin University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction
- What is being tested?
- thrombolysis and PCI of A type and thrombolysis and PCI of B type
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second hospital of Jilin university
Changchun, Jilin, 130041
He Wang, Doctor, 043188796625, wanghe221@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- thrombolysis and PCI of A type, thrombolysis and PCI of B type
- Keywords
- Percutaneous Coronary Intervention, STEMI, Thrombosis
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombolysis and PCI of A typeCombination product
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 typeCombination product
STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | 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. Receives: Combination Product: thrombolysis and PCI of A type |
| B group | Experimental | 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. Receives: Combination Product: thrombolysis and PCI of B type |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
The incidence of no reflow
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
Measured: intraoperative
Secondary outcomes (3)
Major Adverse Cardiovascular Events （MACE）
Death and recurrence of myocardial infarction and target vessels revascularization
Measured: 1 month, 3 month,6 month,12 month
Post-PCI heart function
The value of ejection fraction will be examined by cardiac ultrasound for heart function.
Measured: 1 month, 3 month,6 month,12 month
The incidence of serious bleeding events
The incidence of serious bleeding events including all cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start17 Apr 2017
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Liu, Doctor, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137212
- Sponsor's protocol ID
- SecondJilinU-2
- Acronym
- SEPCIT
- Status last verified
- Apr 2017
- First submitted
- 16 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: when the investigators complete the study and publish our data
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time
- ClinicalTrials.gov ID
- NCT03137212
- Acronym / sponsor ID
- SEPCIT / SecondJilinU-2
- Keywords
- Percutaneous Coronary Intervention, STEMI, Thrombosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Combination Product: thrombolysis and PCI of A typeSTEMI 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 | Experimental | Combination Product: thrombolysis and PCI of B typeSTEMI 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombolysis and PCI of A typeSTEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis. | Combination product | A group |
| thrombolysis and PCI of B typeSTEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis. | Combination product | B group |
Primary outcome
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.
The incidence of no reflow
Time frame: intraoperative
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
3 secondary outcomes
Major Adverse Cardiovascular Events （MACE）
Time frame: 1 month, 3 month,6 month,12 month
Post-PCI heart function
Time frame: 1 month, 3 month,6 month,12 month
The incidence of serious bleeding events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: Yes. when the investigators complete the study and publish our data
Related trials for Acute ST Segment Elevation Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Active, not recruiting
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Acute Myocardial Infarction, Coronary Artery Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Liu, Doctor principal investigator
Second Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thrombolysis and PCI of A type and thrombolysis and PCI of B type in people with Acute ST Segment Elevation Myocardial Infarction, run by Second Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Liu, Doctor (043188796598, liubin3333@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-PCI（percutaneous coronary intervention） myocardial perfusion (TIMI flow grade) (time frame: intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.