Status:
UNKNOWN
Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial Infarction
Lead Sponsor:
Harbin Medical University
Collaborating Sponsors:
Tasly Pharmaceuticals, Inc.
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following t...
Detailed Description
Eligible patients with STEMI who meet the Inclusion/Exclusion Criteria will receive thrombolytic therapy, and then be transferred to the PCI center for coronary angiography (CAG). Patients having a ta...
Eligibility Criteria
Inclusion
- Inpatients who meet all of the following criteria can be included in the study:
- Age: 18-75 years old;
- A confirmed diagnosis of STEMI with symptom onset within 12 h;
- STEMI criteria:
- Patient has a history of chest pain/discomfort;
- 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);
- 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
- Patients are not eligible for enrollment if they meet any of the following criteria:
- A contraindication to thrombolysis;
- An estimated survival time ≤ 12 months;
- Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
- Known to be participating in any other clinical trial;
- Pregnant or lactating women, or women experiencing their menstrual period;
- Weight \< 40 Kg or \> 125 Kg;
- Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
- A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
- Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04663932
Start Date
December 22 2020
End Date
March 1 2023
Last Update
April 4 2022
Active Locations (1)
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1
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000