2024-10-24
minor
Study Status, Contacts/Locations, References v6
Primary completion date2025-01-01→2026-12-31
Completion date2026-01-01→2027-12-31
Study sites15→61
2023-07-20
minor
Study Status, Outcome Measures, Contacts/Locations v5
Secondary endpointsdetails revised at 2 of 12 entries
2023-05-05
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-09-01→2025-01-01
Completion date2025-10-01→2026-01-01
Start dateestimated 2023-03-10→confirmed 2023-04-08
Study sites12→13
Eligibility criteria+32 characters
[...] andomization ≤12 hours
Primary PCI expected to be performed within≥30 minutes, and ≤120 minutes
Exclusion Criteria:
Cardiogenic shock
Active bleeding or known at high risk of bleeding (including grade Ⅲ or Ⅳ retinopath [...] e or TIA in the past 6 months
History of hemorrhagic stroke
Platelet count <100×10^9/L or hemoglobin <100 g/L
Known intracranial aneurysm
Severe trauma, surgery or head i [...] month
Suspected aortic dissection or infective endocarditis
Recent puncturePuncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
Currently tak [...] icoagulants
P [...]
Secondary endpointsdetails revised at 3 of 12 entries
2023-02-09
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2025-09-01→2024-09-01
Completion date2026-01-01→2025-10-01
Start date2023-01-01→2023-02-25
Enrollment target2000→2260
Study sites1→12
InterventionsNormal saline (Drug), Recombinant staphylokinase (Drug)→Placebo (Drug), Recombinant staphylokinase (Drug)
Eligibility criteria-366 characters
Inclusion Criteria:
Age 18~-75 years old, weight ≥45 45kg,kg
Diagnosed genderas isSTEMI not(meeting limited.the following two conditions simultaneously)
DiagnosisIschemic ofchest acutepain lasts ≥ 30 minutes
ECG indicates that ST-segment elevation myocardial infarction (both of thetwo following): (A) Ischemic chest pain lastingor more thancontiguous 30precordial minutes; (B) Electrocardiogram indicates ST-segment elevationleads ≥ 0.1mV1 in 2 or more limb leadsmV, or ST-segment elevation ≥of 0.2mV in 2two or more adjacentcontiguous chestprecordial leads ≥ 0.2 mV
Time from onset of persistent is [...] [...]
Secondary endpoints8 to 11 entries
TotalEach rateof the following cardiac and cerebrovascular events
NT-proBNP
CMR indexes
LVEF assessed by echocardiogram
The percentage of TIMI grade 3 + TIMI grade 2 of blood flow in coronary angiography after 60 minutes of use of study medication
Rate of TIMI grade 3 of blood flow in coronary angiography after 60 minutes of use of study medication
Total rate of TIMI grade 3 + TIMI grade 2 of blood flow in first coronary angiography within 1 hour of the use of study medicati [...] grade 2 and 3 prior to PCI
The percentage of TIMI flow grade 3 prior to PCI
The percentage of TIMI flow grade 2 and 3 af [...] [...]
Primary endpoints2 to 1 entries
Efficacy end point: major adverse cardiovascular events
Safety end point: bleeding eventsMACE
Study description-91 characters
[...] racardiac pressure, and eventually progress to heart failure (HF), which seriously affects the prognosis of patients.
The FAS [...] for early reperfusion treatment.
In addition, the thrombus loadburden in the coronary artery increases with the prolongation of i [...] implantation in the coronary artery with excessive thrombus loadburden is prone to slow blood flow or no reflow, resulting in the [...] nes suggest that if the estimated transit time is more than 2120 hoursminutes, thrombolytic therapy should be performed before transport; If the estimated transfer time is less than 2120 hoursminutes, it can be dire [...] [...]
Study title+20 characters
Efficacy and Safety of ana EarlyHalf-dose PhaseBolus Single-bolusof r-SAK forPrior Acuteto Primary PCI in ST-elevation Myocardial Infarction
2022-07-11
minor
Study Status, Outcome Measures, Eligibility v1
Primary completion date2024-09-01→2025-09-01
Completion date2024-12-01→2026-01-01
Start date2022-09-01→2023-01-01
Eligibility criteria+38 characters
[...] : (A) Ischemic chest pain lasting more than 30 minutes; (B) ECGElectrocardiogram indicates ST-segment elevation ≥ 0.1mV in 2 or more limb le [...] and renal impairment, including ALT, AST > 3 x ULN and eGFR<1530 mL/min/1.73m^2
(calculated based on CKD-EPI equation).
Know [...] past 3 months.
Having a history of myocardial infarction or CABGcoronary artery bypass graft.
Having taken antiplatelet drugs after pain onset, such as [...]
Secondary endpoints4 to 8 entries
MACETotal occurredrate of TIMI grade 3 + TIMI grade 2 of blood flow in first coronary angiography within 1 month,hour of the use of study medication
Total rate of TIMI grade 3 months,of 6blood months,flow 9in monthsfirst andcoronary 12 months
Bleeding events occurredangiography within 1 monthhour of the use of study medication
Rate of slow-flow, no-reflow, TIMI grade 3 months+ TIMI grade 2 and TIMI grade 3 after primary PCI
Non-major bleeding events in 30 days after the use of study medication (BARC I, 6II)
Major months,bleeding 9events months andin 12 months after the use of study medication [...]