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RECRUITING
NCT05410925
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Recombinant staphylokinase

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

DRUG

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