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Taking people in ChinaPhase 4

Tests recombinant staphylokinase before heart stent procedure in heart attack patients

Tests a clot-dissolving drug given before stenting in adults with ST-elevation heart attack.

Plain-language title generated from the registry record
Registry title: Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction

Key facts

Where
Changzhou, Chongqing, Dalian, Daqing, Dongguan, Fengcheng, Guangzhou, Hainan, Hangzhou, Hefei, Huai'an, Lianyungang, Liyang, Nanchang, Nanjing, Nanning, Nantong, Neimeng, Qingdao, Shandong, Shanghai, Shenyang, Shenzhen, Suining, Suqian, Suzhou, Taihe, Taishan, Taizhou, Wenzhou, Wuxi, Xuzhou, Yancheng, Yangzhou, Zhengzhou, and Zhenjiang, ChinaSee the 61 sites
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT05410925, who can take part

Where in China

  • Changzhou Second People's HospitalChangzhou, ChinaTaking people
  • Changzhou Wujin People's HospitalChangzhou, ChinaTaking people
  • The First People's Hospital Of ChangzhouChangzhou, ChinaTaking people
  • Chongqing Hospital of Jiangsu Province HospitalChongqing, ChinaTaking people
  • The Second Affiliated Hospital of Dalian Medical UniversityDalian, ChinaTaking people
  • Daqing Oilfield General HospitalDaqing, ChinaTaking people
  • Dongguan People's HospitalDongguan, ChinaTaking people
  • Fengcheng People's HospitalFengcheng, ChinaTaking people
  • General Hospital of Southern Theatre CommandGuangzhou, ChinaTaking people
  • The Second Affiliated Hospital of Hainan Medical UniversityHainan, ChinaTaking people
  • The Affiliated Hospital of Hangzhou Normal UniversityHangzhou, ChinaTaking people
  • The Second Affiliated Hospital of Zhejiang University Medical CollegeHangzhou, ChinaTaking people
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
  • Huai'an First People's HospitalHuai'an, ChinaTaking people
  • Huai'an Second People's HospitalHuai'an, ChinaTaking people
  • Donghai Country People's HospitalLianyungang, ChinaTaking people
  • The First People's Hospital of LianyungangLianyungang, ChinaTaking people
  • The Second People's Hospital of LianyungangLianyungang, ChinaTaking people
  • Liyang Hospital of Jiangsu Province HospitalLiyang, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • Nanjing Tongren HospitalNanjing, ChinaTaking people
  • Sir Run Run Hospital, Nanjing Medical UniversityNanjing, ChinaTaking people
  • The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
  • The Fourth Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
  • Nanjing Qixia District HospitalNanning, ChinaTaking people
  • Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
  • Nantong First People's HospitalNantong, ChinaTaking people
  • The People's Hospital of ZhalaiteNeimeng, ChinaTaking people
  • QingDao Municipal HospitalQingdao, ChinaTaking people
  • Qilu Hospital of Shandong UniversityShandong, ChinaTaking people
  • Renji Hospital affiliated to Shanghai Jiaotong UniversityShanghai, ChinaTaking people
  • Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai, ChinaTaking people
  • The People's Hospital of Liaoning ProvinceShenyang, ChinaTaking people
  • Shenzhen People's HospitalShenzhen, ChinaTaking people
  • Suining County People's HospitalSuining, ChinaTaking people
  • Nanjing Drum Tower Hospital Group Suqian HospitalSuqian, ChinaTaking people
  • Suqian First HospitalSuqian, ChinaTaking people
  • Suzhou Dushu Lake HospitalSuzhou, ChinaTaking people
  • Suzhou Municipal HospitalSuzhou, ChinaTaking people
  • Suzhou Municipal Hospital of Anhui ProvinceSuzhou, ChinaTaking people
  • The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
  • Wanbei Coal-Electricity Group General HospitalSuzhou, ChinaTaking people
  • Taihe County Traditional Chinese Medicine HospitalTaihe, ChinaTaking people
  • Taishan People's HospitalTaishan, ChinaTaking people
  • Taizhou People's HospitalTaizhou, ChinaTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
  • The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
  • Affiliated Hospital of Jiangnan UniversityWuxi, ChinaTaking people
  • Wuxi People's HospitalWuxi, ChinaTaking people
  • Wuxi Second People's HospitalWuxi, ChinaTaking people
  • The affiliated hospital of xuzhou medical universityXuzhou, ChinaTaking people
  • The People's Hospital of Jiawang District of Xuzhou CityXuzhou, ChinaTaking people
  • Xuzhou Central HospitalXuzhou, ChinaTaking people
  • Yancheng NO.1 People's HospitalYancheng, ChinaTaking people
  • Affiliated Hospital of Yangzhou UniversityYangzhou, ChinaTaking people
  • Subei People's Hospital of Jiangsu provinceYangzhou, ChinaTaking people
  • Fuwai Central China Cardiovascular HospitalZhengzhou, ChinaTaking people
  • The 7th People's Hospital of ZhengzhouZhengzhou, ChinaTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
  • Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaTaking people
  • Zhenjiang First People's HospitalZhenjiang, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
The First Affiliated Hospital with Nanjing Medical University
Trial code
NCT05410925
Record updated
30 October 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Severe trauma, surgery or head injury within 1 month; Currently taking anticoagulants; Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset; 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; Poorly controlled hypertension ( ≥180/110 mmHg); Known allergy to r-SAK; History of chronic total occlusion, myocardial infarction or CABG; Patients with other conditions that made them unsuitable to be recruited at the discretion of the investigators; Known history of anemia with hemoglobin level <10 g/dL; Known history of thrombocytopenia with platelet count <100×10⁹/L; 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); Cardiogenic shock; Known intracranial aneurysm; Suspected aortic dissection or infective endocarditis; Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture); Pregnancy, lactation, or planning for pregnancy.

ClinicalTrials.gov NCT05410925