Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction
NCT ID: NCT04663932
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
240 participants
INTERVENTIONAL
2020-12-22
2023-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis
NCT00811772
Impact of Stent Length and Diameter on Patients Undergoing Primary PCI
NCT04110691
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography
NCT01875835
Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
NCT02197559
POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment
NCT02121223
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All subjects will be recorded postoperative microcirculation perfusion and ST-segment drop of electrocardiogram and followed up by telephone or in the clinic at 1, 6, and 12 months after discharge from the hospital to obtain information including their general condition, chief complaints or discomforts, details of taking their oral medications, recent relevant test results, and to evaluate the primary endpoint, secondary endpoints.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
immediate stenting group
Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
immediate stenting group(one-step strategy)
Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
deferred stenting group
Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
deferred stenting group (two-step strategy)
Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
immediate stenting group(one-step strategy)
Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
deferred stenting group (two-step strategy)
Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Age: 18-75 years old;
2. A confirmed diagnosis of STEMI with symptom onset within 12 h;
STEMI criteria:
1. Patient has a history of chest pain/discomfort;
2. ST elevation ≥ 0.1 mV in at least two contiguous leads of an ECG on admission (\> 30 minutes; ≥ 0.2 mV required for V2 and V3 ) or the development of new left bundle branch block (LBBB);
3. an increase in cardiac biomarkers (troponin, CK-MB) above the 99th percentile of the laboratory upper reference limit; 3. Time from FMC to wire crossing estimated to be \> 120 min; 4. Has a target vessel with TIMI grade 3 flow shown as by CAG and ≥ 50% angiographic stenosis after thrombus aspiration; 5. Has culprit lesions identified as primary lesions; 6. Signed the written informed consent form.
Exclusion Criteria
1. A contraindication to thrombolysis;
2. An estimated survival time ≤ 12 months;
3. Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
4. Known to be participating in any other clinical trial;
5. Pregnant or lactating women, or women experiencing their menstrual period;
6. Weight \< 40 Kg or \> 125 Kg;
7. Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
8. A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
9. Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tasly Pharmaceuticals, Inc.
INDUSTRY
Harbin Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yu Bo
The Second Affiliated Hospital of Harbin Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FISSTEMI-phase I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.