[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myocardial-infarction-of-left-ventricle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myocardial-infarction-of-left-ventricle":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100639639","phase-2-recombinant-human-thymosin-beta-4-for-injectionnl005-for-acute-myocardial-infarction-100639639",false,"NCT07586865","Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase IIc Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Recombinant Human Thymosin Beta 4 Injection (NL005) in Patients With Acute Myocardial Infarction","Inclusion Criteria:\n\n* Willing and able to provide written informed consent (by the participant or legally authorized representative)\n* Aged 18 to 75 years old, any sex\n* Diagnosis of ST-segment elevation myocardial infarction (STEMI) with electrocardiogram (ECG) meeting protocol-specified ST-elevation criteria, and scheduled to undergo primary percutaneous coronary intervention (PCI)\n* OR, regardless of ECG criteria, the participant has a completely or nearly completely blocked (TIMI flow grade 0 or 1) proximal or mid left anterior descending (LAD) coronary artery as the single culprit vessel\n* The blocked LAD artery has no visible collateral blood supply from other coronary arteries (Rentrop grade 0)\n* Total myocardial ischemic time (time from chest pain onset to guidewire passage during PCI) meets one of the following: 1. More than 2 hours and less than 6 hours of ischemic time, with either post-PCI LAD TIMI flow grade of 2 or less, or left ventricular ejection fraction (LVEF) of 50% or lower measured by cardiac ultrasound during PCI hospitalization; 2. Between 6 and 24 hours of ischemic time (inclusive)\n* Males and females of childbearing potential must agree to use adequate contraception (such as hormonal or barrier methods, or abstinence) throughout the study\n\nExclusion Criteria:\n\n* Prior history of acute myocardial infarction, chronic total coronary occlusion, coronary thrombolysis, PCI, or coronary artery bypass graft surgery\n* Diagnosis of severe acute heart failure (Killip class III or higher) or chronic heart failure (NYHA functional class III or higher)\n* Severe, uncontrolled arrhythmia that cannot be corrected\n* Presence of aortic dissection\n* Severe liver or kidney dysfunction\n* History of stroke within the past 6 months\n* Current or past diagnosis of any malignancy\n* Blood pressure that remains at or above 180 mmHg systolic and\u002For 110 mmHg diastolic despite adequate antihypertensive treatment\n* History of clinically significant allergic reaction, especially known allergy to protein or biologic drugs\n* Participation in another clinical study within 3 months before screening\n* Unable to undergo cardiac magnetic resonance (CMR) imaging (e.g., due to implanted metal devices, severe claustrophobia, or other contraindications)\n* Any other condition that the investigator believes makes participation unsuitable (for example, the need for urgent or planned revascularization of non-LAD coronary arteries within 3 months)","ALL","18 Years","75 Years",{"count":20,"type":21},189,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this phase IIc clinical trial is to learn if recombinant human thymosin beta 4 injection (NL005) works to treat heart damage in people who have had a serious type of heart attack called ST-segment elevation myocardial infarction (STEMI) and have been treated with emergency percutaneous coronary intervention (PCI, a procedure to open the blocked artery). It will also learn about the safety of NL005. The main questions it aims to answer are:\n\n* Does NL005 lower the size of permanent heart muscle damage measured by cardiac magnetic resonance (CMR) scan 90 days after treatment?\n* What medical problems do participants have when taking NL005?\n\nResearchers will compare two different doses of NL005 to a placebo (a look-alike substance that contains no drug) to see if NL005 works better to reduce heart damage caused by the heart attack.\n\nParticipants will:\n\n* Receive NL005 or placebo through a vein within 4 hours after the PCI procedure, then once a day for 7 days\n* Stay in the hospital for the first week for monitoring, blood draws, and electrocardiograms (heart tracings)\n* Have a CMR scan on Day 6 and Day 90 to measure the size of the heart injury\n* Return to the hospital for checkups on Day 30 and Day 90\n* Be contacted by the study team (by phone or online) 3 times during the first year and come back to the hospital on Day 360 to check long-term recovery",[27,28,29,30,31],"Acute Myocardial Infarction (AMI)","Acute Myocardial Infarction of Anterior Wall","Acute Myocardial Infarction With ST Elevation","Acute Myocardial Infarction of Left Ventricle","Acute Myocardial Infarction With ST Segment Elevation",[33,34,35],"AMI","CMR","cardioprotective","NOT_YET_RECRUITING","2026-05-08",{"date":39,"type":40},"2026-05-14","ACTUAL",{"date":42,"type":21},"2026-05-18",{"date":44,"type":21},"2028-05-17",{"name":46,"class":47},"Beijing Northland Biotech. Co., Ltd.","INDUSTRY"]