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ST Elevation Myocardial InfarctionPhase 4OPTIMA-6NCT05410925

Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction

A Phase 4 study testing Recombinant staphylokinase in people with ST Elevation Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 61 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
Recombinant staphylokinase
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,260 participants
Where
61 sitesChina
Study dates
8 Apr 2023to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 6 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
Show all 18Show fewer
  • Suspected aortic dissection or infective endocarditis
  • Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
  • Currently taking anticoagulants
  • Known history of anemia with hemoglobin level <10 g/dL
  • Known history of thrombocytopenia with platelet count <100×10⁹/L
  • 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, calculated based on CKD-EPI)
  • 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

Trial locations and contacts

61 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chunjian Li, PHD contact

+86 13701465229

lijay@njmu.edu.cn

Chen Li, MD contact

+86 13913886986

lcicewind@outlook.com

61 sites in 1 country

China61 sites, 61 recruiting

  • Changzhou Second People's Hospital

    Changzhou

    Xin Chen, MD

    Recruiting

  • Changzhou Wujin People's Hospital

    Changzhou

    Jianqiang Xiao, MD

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou

    Ling Yang, MD

    Recruiting

  • Chongqing Hospital of Jiangsu Province Hospital

    Chongqing

    Junhong Wang, MD

    Hongyan Xing

    Recruiting

  • The second Affiliated Hospital of Dalian Medical University

    Dalian

    Xin Zhao, MD

    Recruiting

  • Daqing Oilfield General Hospital

    Daqing

    Zhiqi Sun, MD

    Recruiting

  • Dongguan People's Hospital

    Dongguan

    Suxia Guo, MD

    Recruiting

  • Fengcheng People's Hospital

    Fengcheng

    Wenbo Li, MD

    Recruiting

  • General Hospital of Southern Theatre Command

    Guangzhou

    Jinxia Zhang, MD

    Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Hainan

    Yuewu Chen, MD

    Recruiting

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou

    Peng Dong, MD, +86 13501352371

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University Medical College

    Hangzhou

    Jun Jiang, MD

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Xianhe Lin, MD

    Recruiting

  • Huai'an First People's Hospital

    Huai'an

    Xiwen Zhang, MD

    Recruiting

  • Huai'an Second People's Hospital

    Huai'an

    Naiquan Yang, MD

    Recruiting

  • Donghai Country People's Hospital

    Lianyungang

    Jianling Zhou, MD

    Recruiting

  • The First People's Hospital of Lianyungang

    Lianyungang

    Bo Zhao, MD

    Recruiting

  • The Second People's Hospital of Lianyungang

    Lianyungang

    Yilian Wang, MD

    Recruiting

  • Liyang Hospital of Jiangsu Province Hospital

    Liyang

    Junhong Wang, MD

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Xiaoping Peng, MD

    Recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Chunjian Li, PHD, +86 13701465229, lijay@njmu.edu.cn

    Chen Li, MD, +86 13913886986, lcicewind@outlook.com

    Recruiting

  • Nanjing Tongren Hospital

    Nanjing

    Jiakuan Wu, MD

    Recruiting

  • Sir Run Run Hospital Nanjing Medical University

    Nanjing

    Chunjian Li, MD

    Recruiting

  • The Fourth Affiliated Hospital of Nanjing Medical University

    Nanjing

    Pingxi Xiao, MD

    Recruiting

  • Nanjing Qixia District Hospital

    Nanning

    Daxing Yang, MD

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong

    Hongzhuan Sheng, MD

    Recruiting

  • Nantong First People's Hospital

    Nantong

    Koulong Zheng, MD

    Recruiting

  • The People's Hospital of Zhalaite

    Neimeng

    Guofeng Chang, MD

    Recruiting

  • Qingdao Municipal Hospital

    Qingdao

    Yibing Shao, MD

    Recruiting

  • Qilu Hospital of Shandong University

    Shandong

    Yuguo Chen, MD

    Recruiting

  • Renji Hospital affiliated to Shanghai Jiaotong University

    Shanghai

    Jun Bu, MD

    Recruiting

  • Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai

    Lei Hou, MD, +86 13564868096

    Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang

    Bo Luan, MD

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen

    Da Yin, MD

    Recruiting

  • Suining County People's Hospital

    Suining

    Ruili Wang, MD

    Recruiting

  • Nanjing Drum Tower Hospital Group Suqian Hospital

    Suqian

    Hao Ding, MD

    Recruiting

  • Suqian First Hospital

    Suqian

    Zhiyong Zhang, MD

    Recruiting

  • Suzhou Dushu Lake Hospital

    Suzhou

    Yafeng Zhou, MD

    Recruiting

  • Suzhou Municipal Hospital of Anhui Province

    Suzhou

    Hailong Qiu, MD

    Recruiting

  • Suzhou Municipal Hospital

    Suzhou

    Jun Zhang, MD, +86 18994427321

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Tingbo Jiang, MD

    Recruiting

  • Wanbei Coal-Electricity Group General Hospital

    Suzhou

    Kun Zhu, MD

    Recruiting

  • Taihe County Traditional Chinese Medicine Hospital

    Taihe

    Daimei Ni, MD

    Recruiting

  • Taishan People&#39;s Hospital

    Taishan

    Yan Chen, MD, +86 13580014030

    Recruiting

  • Taizhou People's Hospital

    Taizhou

    Li Zhu, MD

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Hao Zhou, MD

    Recruiting

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Xueqiang Guan, MD

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi

    Xiaoyan Wang, MD

    Recruiting

  • Wuxi People's Hospital

    Wuxi

    Ruxing Wang, MD

    Recruiting

  • Wuxi Second People's Hospital

    Wuxi

    Yan Jin, MD

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

    Tongda Xu, MD

    Recruiting

  • The People's Hospital of Jiawang District of Xuzhou City

    Xuzhou

    Yunjun Li, MD

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Bing Han, MD

    Recruiting

  • Yancheng No.1 People's Hospital

    Yancheng

    Yunfeng Ju, MD

    Recruiting

  • Affiliated Hospital of Yangzhou University

    Yangzhou

    Kaizheng Gong, MD

    Recruiting

  • Subei People's Hospital of Jiangsu province

    Yangzhou

    Yong Xie, MD

    Recruiting

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou

    Xiaohui Zheng, MD

    Recruiting

  • The 7th People's Hospital of Zhengzhou

    Zhengzhou

    Yong Dong, MD

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Zhanying Han, MD

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

    Wei Yuan, MD

    Recruiting

  • Zhenjiang First People's Hospital

    Zhenjiang

    Tao Rui, MD

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction: a Multicenter Randomized Double-blind Placebo-controlled Trial (OPTIMA-6)

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.

In this investigator-initiated, prospective, multi-center, randomized, double-blind, placebo-controlled trial, subjects meeting the inclusion/exclusion criteria should be randomly assigned 1:1 to the trial group (r-SAK) or the control group (placebo). The risk of major adverse cardiovascular events within 90 days will be observed.

Read the detailed description

Acute myocardial infarction (AMI) is a serious and critical disease that causes acute coronary artery stenosis, spasm or occlusion due to the rupture or erosion of coronary artery plaque, resulting in myocardial ischemia and necrosis. Myocardial ischemia and necrosis can cause myocardial cell loss, ventricular remodeling and local inflammatory reaction, leading to decreased cardiac output or increased intracardiac pressure, and eventually progress to heart failure (HF), which seriously affects the prognosis of patients. The FAST-MI study found that 37.5% of AMI patients were complicated with HF, and the 1-year mortality of these patients was significantly increased. Early reperfusion treatment as an effective means of AMI treatment can promote myocardial reperfusion, save dying myocardium and reduce infarct area, which is of great significance to improve the clinical prognosis of patients.

At this stage, many primary hospitals do not have the conditions for emergency percutaneous coronary intervention (PCI). Transferring patients to PCI hospitals takes a lot of time, delaying the best time for early reperfusion treatment. In addition, the thrombus burden in the coronary artery increases with the prolongation of ischemia time. Stent implantation in the coronary artery with excessive thrombus burden is prone to slow blood flow or no reflow, resulting in the occurrence of major adverse cardiovascular events (MACE). In view of the above problems, guidelines suggest that if the estimated transit time is more than 120 minutes, thrombolytic therapy should be performed before transport; If the estimated transfer time is less than 120 minutes, it can be directly transferred to the PCI hospital.

However, it remains uncertain whether adjunctive thrombolytic therapy administered immediately prior to primary PCI improves outcomes in patients undergoing the procedure within 120 minutes ("facilitated PCI"). Multiple previous studies comparing facilitated PCI with primary PCI found facilitated PCI to be inferior in terms of clinical outcomes, while other studies based on reduced-dose thrombolysis confirmed the superiority of facilitated PCI in better patency of infarct-related artery (IRA). Recombinant staphylokinase (r-SAK), as the third-generation thrombolytic agent, may serve as the potential thrombolytic drug to contemporary facilitated PCI by virtue of its high fibrinolytic activity and fibrin selectivity.

Staphylokinase (SAK) is produced by Staphylococcus aureus and it is a protein containing 136 amino acid residues. Its ability for dissolving blood clots was first discovered in 1948. Studies have shown that SAK is not directly convert plasminogen (PLG) into plasminogen (PLi), but first combines with PLG in a 1:1 ratio to form a complex. The complex can lead to the exposure of PLG active site, from single chain to double chain PLi, resulting to form an active SAK-PLI complex, which subsequently activates PLG molecules. Then PLG transforms into PLi and further dissolve the thrombus.

R-SAK was developed in 1990 by Shanghai Institute of Plant and Biological Physiology. It is a gene recombinant drug prepared by molecular cloning of SAK gene in Escherichia coli. Its biological characteristics are very similar to natural SAK, and r-SAK is a highly fibrin-specific fibrinolysis agent. R-SAK is considered to be one of the most promising thrombolytic drugs due to its high thrombolysis activity (especially in platelet-rich arterial thrombosis), inactivation of system fibrinolysis, and few side effects. Clinical studies have shown that the efficacy of r-SAK in the treatment of AMI is better than urokinase, comparable to RT-PA, and it does not increase serious bleeding complications such as intracranial hemorrhage.

In terms of pharmacokinetics, r-SAK has a fast distribution and a long action time in human body. Half-lives of distribution term is 13.30±2.06min and elimination term is 67.94±21.39min when intravenous injection 10 mg r-SAK in 30min. A single bolus of r-SAK as early as possible during the first medical contact (such as prehospital care or primary hospitals or medical centers with conditional PCI) can maximize the time window for reperfusion therapy.

Achieving early reperfusion by means of facilitated PCI is consistent with the core of STEMI treatment, but the efficacy and safety of facilitated PCI are still controversial. OPTIMA-6, designed as shorter symptom onset to treatment time, a half-dose thrombolytic agent, and upstream use of the potent antiplatelet agent, will therefore evaluate the efficacy and safety of a half-dose bolus of r-SAK vs. placebo prior to primary PCI to inform clinical practice of contemporary facilitated PCI in patients with STEMI.

Being tested
Recombinant staphylokinase, Placebo
Keywords
ST Elevation Myocardial Infarction, Recombinant Staphylokinase, Thrombolysis
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant staphylokinaseDrug

    Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction

  • PlaceboDrug

    Intravenous injection of placebo is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction

Study groups in NCT05410925
Study groupRoleWhat they receive
r-SAK groupExperimentalintravenous injection of single-bolus 5 mg r-SAK in 3 min
Receives: Drug: Recombinant staphylokinase
placebo groupPlacebo comparatorintravenous injection of placebo in 3 min
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

    Defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia

    Measured: Within 90 days

Secondary outcomes (12)

  1. Each of the following cardiac and cerebrovascular events

    Including all-cause death, cardiovascular death, reinfarction, stroke, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia, cardiogenic rehospitalization, ventricular septal rupture, papillary muscle rupture, cardiac rupture, ventricular aneurysm

    Measured: Within 90 days

  2. NT-proBNP

    The level of NT-proBNP

    Measured: 1 day before discharge or day 7, day 90±3

  3. CMR indexes

    Including infarct size, left ventricular ejection fraction (LVEF), microvascular obstruction (MVO) and intramuscular hemorrhage (IMH), assessed by cardiac magnetic resonance (CMR)

    Measured: Day 5

  4. LVEF assessed by echocardiogram

    LVEF assessed by echocardiogram

    Measured: Day 90±3

  5. The percentage of TIMI flow grade 2 and 3 prior to PCI

    The percentage of thrombolysis in myocardial infarction (TIMI) flow grade 2 and 3 prior to PCI

    Measured: Immediately prior to PCI

  6. The percentage of TIMI flow grade 3 prior to PCI

    The percentage of TIMI flow grade 3 prior to PCI

    Measured: Immediately prior to PCI

  7. The percentage of TIMI flow grade 2 and 3 after PCI

    The percentage of TIMI flow grade 2 and 3 after PCI

    Measured: Immediately after PCI

  8. The percentage of TIMI flow grade 3 after PCI

    The percentage of TIMI flow grade 3 after PCI

    Measured: Immediately after PCI

  9. MACE

    Defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia

    Measured: Within 360 days

  10. Each of the following cardiac and cerebrovascular events

    Including all-cause death, cardiovascular death, reinfarction, ischemic stroke, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia, cardiogenic rehospitalization, ventricular septal rupture, papillary muscle rupture, cardiac rupture, ventricular aneurysm

    Measured: Within 360 days

  11. NT-proBNP

    The level of NT-proBNP

    Measured: Day 360±7

  12. LVEF assessed by echocardiogram

    LVEF assessed by echocardiogram

    Measured: Day 360±7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start8 Apr 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410925
Sponsor's protocol ID
018
Acronym
OPTIMA-6
Status last verified
Oct 2026
First submitted
6 Jun 2022
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gulati R, Behfar A, Narula J, Kanwar A, Lerman A, Cooper L, Singh M. Acute Myocardial Infarction in Young Individuals. Mayo Clin Proc. 2020 Jan;95(1):136-156. doi: 10.1016/j.mayocp.2019.05.001.

    PubMed 31902409

  • Bahit MC, Kochar A, Granger CB. Post-Myocardial Infarction Heart Failure. JACC Heart Fail. 2018 Mar;6(3):179-186. doi: 10.1016/j.jchf.2017.09.015.

    PubMed 29496021

  • Heusch G, Libby P, Gersh B, Yellon D, Bohm M, Lopaschuk G, Opie L. Cardiovascular remodelling in coronary artery disease and heart failure. Lancet. 2014 May 31;383(9932):1933-43. doi: 10.1016/S0140-6736(14)60107-0. Epub 2014 May 13.

    PubMed 24831770

  • Juilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.

    PubMed 22357361

  • Bradley EH, Nallamothu BK, Herrin J, Ting HH, Stern AF, Nembhard IM, Yuan CT, Green JC, Kline-Rogers E, Wang Y, Curtis JP, Webster TR, Masoudi FA, Fonarow GC, Brush JE Jr, Krumholz HM. National efforts to improve door-to-balloon time results from the Door-to-Balloon Alliance. J Am Coll Cardiol. 2009 Dec 15;54(25):2423-9. doi: 10.1016/j.jacc.2009.11.003.

    PubMed 20082933

  • Mangin L, Lotfi M, Puie P, Yayehd K, Ispas A, Belle L. [Management of high thrombus burden in primary PCI]. Ann Cardiol Angeiol (Paris). 2017 Dec;66(6):380-384. doi: 10.1016/j.ancard.2017.10.016. Epub 2017 Oct 31. French.

    PubMed 29096903

  • Bai M, Pan CL, Zhao J, Zhao CR, Zhang B, Mu ZY, Meng XX, Zhou XH, Zhu YQ, Zhang Z. [Safety and efficacy of regional transport combined with PCI model in patients with STEMI after thrombolysis in northwest China]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Aug 24;48(8):641-647. doi: 10.3760/cma.j.cn112148-20200228-00138. Chinese.

    PubMed 32847319

  • Schwartz R, Weiss AT, Leibowitz D, Rot D, Pollak A, Lotan C, Alcalai R. Thrombolysis followed by coronary angiography versus primary percutaneous coronary intervention in non-anterior ST-elevation myocardial infarction. J Invasive Cardiol. 2013 Dec;25(12):632-6.

    PubMed 24296382

  • Ren K, Gong H, Huang J, Liu Y, Dong Q, He K, Tian L, Zhang F, Yu A, Wu C. Thrombolytic and anticoagulant effects of a recombinant staphylokinase-hirudin fusion protein. Thromb Res. 2021 Dec;208:26-34. doi: 10.1016/j.thromres.2021.10.005. Epub 2021 Oct 14.

    PubMed 34688099

  • Vanderschueren S. [Staphylokinase for a better thrombolytic treatment of heart and platelet diseases]. Verh K Acad Geneeskd Belg. 2000;62(1):69-75. Dutch.

    PubMed 10769618

  • Ueshima S, Matsuo O. Development of new fibrinolytic agents. Curr Pharm Des. 2006;12(7):849-57. doi: 10.2174/138161206776056065.

    PubMed 16515501

  • Yamamoto J, Kawano M, Hashimoto M, Sasaki Y, Yamashita T, Taka T, Watanabe S, Giddings JC. Adjuvant effect of antibodies against von Willebrand Factor, fibrinogen, and fibronectin on staphylokinase-induced thrombolysis as measured using mural thrombi formed in rat mesenteric venules. Thromb Res. 2000 Mar 1;97(5):327-33. doi: 10.1016/s0049-3848(99)00184-x.

    PubMed 10709908

  • Szemraj J, Stankiewicz A, Rozmyslowicz-Szerminska W, Mogielnicki A, Gromotowicz A, Buczko W, Oszajca K, Bartkowiak J, Chabielska E. A new recombinant thrombolytic and antithrombotic agent with higher fibrin affinity - a staphylokinase variant. An in-vivo study. Thromb Haemost. 2007 Jun;97(6):1037-45. doi: 10.1160/th06-10-0562.

    PubMed 17549308

  • Vakili B, Nezafat N, Negahdaripour M, Yari M, Zare B, Ghasemi Y. Staphylokinase Enzyme: An Overview of Structure, Function and Engineered Forms. Curr Pharm Biotechnol. 2017;18(13):1026-1037. doi: 10.2174/1389201019666180209121323.

    PubMed 29424308

  • Li CJ, Huang J, Yang ZJ, Cao KJ. Thrombolytic efficacy of native recombinant staphylokinase on femoral artery thrombus of rabbits. Acta Pharmacol Sin. 2007 Jan;28(1):58-65. doi: 10.1111/j.1745-7254.2007.00455.x.

    PubMed 17184583

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Recombinant staphylokinase in people with ST Elevation Myocardial Infarction, run by The First Affiliated Hospital with Nanjing Medical University at 61 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chunjian Li, PHD (+86 13701465229, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: Within 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05410925, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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