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
- Diseases
- Coronary artery disease
- 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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital Of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Changzhou Wujin People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Changzhou Second People's Hospital Coordinator of this site? Confirm its status | Changzhou | China | Recruiting |
| Chongqing Hospital of Jiangsu Province Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The Second Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Daqing Oilfield General Hospital Coordinator of this site? Confirm its status | Daqing | China | Recruiting |
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Recruiting |
| Fengcheng People's Hospital Coordinator of this site? Confirm its status | Fengcheng | China | Recruiting |
| General Hospital of Southern Theatre Command Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Hainan | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University Medical College Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Affiliated Hospital of Hangzhou Normal University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Huai'an Second People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| The Second People's Hospital of Lianyungang Coordinator of this site? Confirm its status | Lianyungang | China | Recruiting |
| Donghai Country People's Hospital Coordinator of this site? Confirm its status | Lianyungang | China | Recruiting |
| The First People's Hospital of Lianyungang Coordinator of this site? Confirm its status | Lianyungang | China | Recruiting |
| Liyang Hospital of Jiangsu Province Hospital Coordinator of this site? Confirm its status | Liyang | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Nanjing Tongren Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Sir Run Run Hospital, Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The Fourth Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Nanjing Qixia District Hospital Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Nantong First People's Hospital Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| The People's Hospital of Zhalaite Coordinator of this site? Confirm its status | Neimeng | China | Recruiting |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Shandong | China | Recruiting |
| Renji Hospital affiliated to Shanghai Jiaotong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The People's Hospital of Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
| Suining County People's Hospital Coordinator of this site? Confirm its status | Suining | China | Recruiting |
| Nanjing Drum Tower Hospital Group Suqian Hospital Coordinator of this site? Confirm its status | Suqian | China | Recruiting |
| Suqian First Hospital Coordinator of this site? Confirm its status | Suqian | China | Recruiting |
| Wanbei Coal-Electricity Group General Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Suzhou Municipal Hospital of Anhui Province Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Suzhou Municipal Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Suzhou Dushu Lake Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Taihe County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Taihe | China | Recruiting |
| Taishan People's Hospital Coordinator of this site? Confirm its status | Taishan | China | Recruiting |
| Taizhou People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Affiliated Hospital of Jiangnan University Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| Wuxi Second People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| The People's Hospital of Jiawang District of Xuzhou City Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Yancheng NO.1 People's Hospital Coordinator of this site? Confirm its status | Yancheng | China | Recruiting |
| Affiliated Hospital of Yangzhou University Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
| Subei People's Hospital of Jiangsu province Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
| The 7th People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Fuwai Central China Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Recruiting |
| Zhenjiang First People's Hospital Coordinator of this site? Confirm its status | Zhenjiang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.