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Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
Sponsor: The First Affiliated Hospital with Nanjing Medical University
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 (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.
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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
2260
Start Date
2023-04-08
Completion Date
2027-12-31
Last Updated
2024-10-28
Healthy Volunteers
No
Conditions
Interventions
Recombinant staphylokinase
Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Placebo
Intravenous injection of placebo is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Locations (61)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Changzhou Second People's Hospital
Changzhou, China
Changzhou Wujin People's Hospital
Changzhou, China
The First People's Hospital of Changzhou
Changzhou, China
Chongqing Hospital of Jiangsu Province Hospital
Chongqing, China
The second Affiliated Hospital of Dalian Medical University
Dalian, China
Daqing Oilfield General Hospital
Daqing, China
Dongguan People's Hospital
Dongguan, China
Fengcheng People's Hospital
Fengcheng, China
General Hospital of Southern Theatre Command
Guangzhou, China
The Second Affiliated Hospital of Hainan Medical University
Hainan, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huai'an First People's Hospital
Huai'an, China
Huai'an Second People's Hospital
Huai'an, China
Donghai Country People's Hospital
Lianyungang, China
The First People's Hospital of Lianyungang
Lianyungang, China
The Second People's Hospital of Lianyungang
Lianyungang, China
Liyang Hospital of Jiangsu Province Hospital
Liyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Tongren Hospital
Nanjing, China
Sir Run Run Hospital Nanjing Medical University
Nanjing, China
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, China
Nanjing Qixia District Hospital
Nanning, China
Affiliated Hospital of Nantong University
Nantong, China
Nantong First People's Hospital
Nantong, China
The People's Hospital of Zhalaite
Neimeng, China
Qingdao Municipal Hospital
Qingdao, China
Qilu Hospital of Shandong University
Shandong, China
Renji Hospital affiliated to Shanghai Jiaotong University
Shanghai, China
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The People's Hospital of Liaoning Province
Shenyang, China
Shenzhen People's Hospital
Shenzhen, China
Suining County People's Hospital
Suining, China
Nanjing Drum Tower Hospital Group Suqian Hospital
Suqian, China
Suqian First Hospital
Suqian, China
Suzhou Dushu Lake Hospital
Suzhou, China
Suzhou Municipal Hospital of Anhui Province
Suzhou, China
Suzhou Municipal Hospital
Suzhou, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Wanbei Coal-Electricity Group General Hospital
Suzhou, China
Taihe County Traditional Chinese Medicine Hospital
Taihe, China
Taishan People's Hospital
Taishan, China
Taizhou People's Hospital
Taizhou, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Affiliated Hospital of Jiangnan University
Wuxi, China
Wuxi People's Hospital
Wuxi, China
Wuxi Second People's Hospital
Wuxi, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
The People's Hospital of Jiawang District of Xuzhou City
Xuzhou, China
Xuzhou Central Hospital
Xuzhou, China
Yancheng No.1 People's Hospital
Yancheng, China
Affiliated Hospital of Yangzhou University
Yangzhou, China
Subei People's Hospital of Jiangsu province
Yangzhou, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Zhenjiang First People's Hospital
Zhenjiang, China