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NCT05410925RecruitingPhase 4

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

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)

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2260 (estimated)
First submitted
6 Jun 2022
Start date
8 Apr 2023
Primary completion date
31 Dec 2026
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT05410925

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 2260
  • From 8 Apr 2023 to the primary completion date, 31 Dec 2026
  • 61 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

  • 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)

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First People's Hospital Of Changzhou
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ChangzhouChinaRecruiting
Changzhou Wujin People's Hospital
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ChangzhouChinaRecruiting
Changzhou Second People's Hospital
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ChangzhouChinaRecruiting
Chongqing Hospital of Jiangsu Province Hospital
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ChongqingChinaRecruiting
The Second Affiliated Hospital of Dalian Medical University
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DalianChinaRecruiting
Daqing Oilfield General Hospital
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DaqingChinaRecruiting
Dongguan People's Hospital
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DongguanChinaRecruiting
Fengcheng People's Hospital
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FengchengChinaRecruiting
General Hospital of Southern Theatre Command
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GuangzhouChinaRecruiting
The Second Affiliated Hospital of Hainan Medical University
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HainanChinaRecruiting
The Second Affiliated Hospital of Zhejiang University Medical College
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HangzhouChinaRecruiting
The Affiliated Hospital of Hangzhou Normal University
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HangzhouChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaRecruiting
Huai'an Second People's Hospital
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Huai'anChinaRecruiting
Huai'an First People's Hospital
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Huai'anChinaRecruiting
The Second People's Hospital of Lianyungang
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LianyungangChinaRecruiting
Donghai Country People's Hospital
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LianyungangChinaRecruiting
The First People's Hospital of Lianyungang
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LianyungangChinaRecruiting
Liyang Hospital of Jiangsu Province Hospital
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LiyangChinaRecruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University
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NanjingChinaRecruiting
Nanjing Tongren Hospital
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NanjingChinaRecruiting
Sir Run Run Hospital, Nanjing Medical University
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NanjingChinaRecruiting
The Fourth Affiliated Hospital of Nanjing Medical University
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NanjingChinaRecruiting
Nanjing Qixia District Hospital
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NanningChinaRecruiting
Affiliated Hospital of Nantong University
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NantongChinaRecruiting
Nantong First People's Hospital
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NantongChinaRecruiting
The People's Hospital of Zhalaite
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NeimengChinaRecruiting
QingDao Municipal Hospital
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QingdaoChinaRecruiting
Qilu Hospital of Shandong University
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ShandongChinaRecruiting
Renji Hospital affiliated to Shanghai Jiaotong University
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ShanghaiChinaRecruiting
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
The People's Hospital of Liaoning Province
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ShenyangChinaRecruiting
Shenzhen People's Hospital
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ShenzhenChinaRecruiting
Suining County People's Hospital
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SuiningChinaRecruiting
Nanjing Drum Tower Hospital Group Suqian Hospital
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SuqianChinaRecruiting
Suqian First Hospital
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SuqianChinaRecruiting
Wanbei Coal-Electricity Group General Hospital
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SuzhouChinaRecruiting
The First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Suzhou Municipal Hospital of Anhui Province
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SuzhouChinaRecruiting
Suzhou Municipal Hospital
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SuzhouChinaRecruiting
Suzhou Dushu Lake Hospital
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SuzhouChinaRecruiting
Taihe County Traditional Chinese Medicine Hospital
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TaiheChinaRecruiting
Taishan People&#39;s Hospital
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TaishanChinaRecruiting
Taizhou People's Hospital
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TaizhouChinaRecruiting
The Second Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaRecruiting
Affiliated Hospital of Jiangnan University
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WuxiChinaRecruiting
Wuxi People's Hospital
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WuxiChinaRecruiting
Wuxi Second People's Hospital
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WuxiChinaRecruiting
The People's Hospital of Jiawang District of Xuzhou City
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XuzhouChinaRecruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
Xuzhou Central Hospital
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XuzhouChinaRecruiting
Yancheng NO.1 People's Hospital
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YanchengChinaRecruiting
Affiliated Hospital of Yangzhou University
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YangzhouChinaRecruiting
Subei People's Hospital of Jiangsu province
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YangzhouChinaRecruiting
The 7th People's Hospital of Zhengzhou
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ZhengzhouChinaRecruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaRecruiting
Fuwai Central China Cardiovascular Hospital
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ZhengzhouChinaRecruiting
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaRecruiting
Zhenjiang First People's Hospital
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ZhenjiangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.