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Tests treatment safety and results for ST Elevation Myocardial Infarction
Official title Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT05410925
What this study is testing
What is Recombinant staphylokinase?
Recombinant staphylokinase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for st elevation myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- As an effective treatment for acute ST-segment elevation myocardial infarction (STEMI), early reperfusion may reduce the infarct size and improve the prognosis of patients. However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary percutaneous coronary intervention (PCI) improves outcomes in patients undergoing the procedure within 120 minutes.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 years, weight ≥45 kg
- Diagnosed as STEMI (meeting the following two conditions simultaneously)
- Ischemic chest pain lasts ≥ 30 minutes
- ECG indicates that ST-segment elevation of two or more contiguous precordial leads ≥ 0.1 mV, or ST-segment elevation of two or more contiguous...
- Time from onset of persistent chest pain to randomization ≤12 hours
You likely can't join if
- Cardiogenic shock
- Active bleeding or known at high risk of bleeding (including grade Ⅲ or Ⅳ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within...
- Ischemic stroke or TIA in the past 6 months
- History of hemorrhagic stroke
- Known intracranial aneurysm
- Severe trauma, surgery or head injury within 1 month
See the full eligibility criteria
- Age 18-75 years, weight ≥45 kg
- Diagnosed as STEMI (meeting the following two conditions simultaneously)
- Ischemic chest pain lasts ≥ 30 minutes
- ECG indicates that ST-segment elevation of two or more contiguous precordial leads ≥ 0.1 mV, or ST-segment elevation of two or more contiguous precordial leads ≥ 0.2 mV
- Time from onset of persistent chest pain to randomization ≤12 hours
- Primary PCI expected to be performed ≥30 minutes, and ≤120 minutes
- Cardiogenic shock
- Active bleeding or known at high risk of bleeding (including grade Ⅲ or Ⅳ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within the past 1 month)
- Ischemic stroke or TIA in the past 6 months
- History of hemorrhagic stroke
- Known intracranial aneurysm
- Severe trauma, surgery or head injury within 1 month
- Suspected aortic dissection or infective endocarditis
- Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
- Currently taking anticoagulants
- Poorly controlled hypertension ( ≥180/110 mmHg)
- Severe hepatic or renal impairment indicated by the consultation or previous history (glutamic-pyruvic transaminase or glutamic oxalacetic transaminase \>3 times upper limit of normal value; eGFR \<15 ml/min/1.73m\^2...
- Known allergy to r-SAK
- Pregnancy, lactation, or planning for pregnancy
- History of chronic total occlusion, myocardial infarction or CABG
- Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset
- Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Changzhou, China
- Chongqing, China
- Dalian, China
- Daqing, China
- Dongguan, China
- Fengcheng, China
- Guangzhou, China
- Hainan, China
- Hangzhou, China
- Hefei, China
- Huai'an, China
- Lianyungang, China
- Liyang, China
- Nanchang, China
- Nanjing, China
- Nanning, China
- Nantong, China
- Neimeng, China
- Qingdao, China
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Changzhou, China; Chongqing, China; Dalian, China; Daqing, China; Dongguan, China and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.