Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- MACE — Within 90 days
Defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia
Trial sites (61)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | Recruiting |
| Changzhou Second People's Hospital | Changzhou | China | Recruiting |
| Changzhou Wujin People's Hospital | Changzhou | China | Recruiting |
| The First People's Hospital of Changzhou | Changzhou | China | Recruiting |
| Chongqing Hospital of Jiangsu Province Hospital | Chongqing | China | Recruiting |
| The second Affiliated Hospital of Dalian Medical University | Dalian | China | Recruiting |
| Daqing Oilfield General Hospital | Daqing | China | Recruiting |
| Dongguan People's Hospital | Dongguan | China | Recruiting |
| Fengcheng People's Hospital | Fengcheng | China | Recruiting |
| General Hospital of Southern Theatre Command | Guangzhou | China | Recruiting |
| The Second Affiliated Hospital of Hainan Medical University | Hainan | China | Recruiting |
| The Affiliated Hospital of Hangzhou Normal University | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China | Recruiting |
| Huai'an First People's Hospital | Huai'an | China | Recruiting |
| Huai'an Second People's Hospital | Huai'an | China | Recruiting |
| Donghai Country People's Hospital | Lianyungang | China | Recruiting |
| The First People's Hospital of Lianyungang | Lianyungang | China | Recruiting |
| The Second People's Hospital of Lianyungang | Lianyungang | China | Recruiting |
| Liyang Hospital of Jiangsu Province Hospital | Liyang | China | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | China | Recruiting |
| Nanjing Tongren Hospital | Nanjing | China | Recruiting |
| Sir Run Run Hospital Nanjing Medical University | Nanjing | China | Recruiting |
| The Fourth Affiliated Hospital of Nanjing Medical University | Nanjing | China | Recruiting |
| Nanjing Qixia District Hospital | Nanning | China | Recruiting |
| Affiliated Hospital of Nantong University | Nantong | China | Recruiting |
| Nantong First People's Hospital | Nantong | China | Recruiting |
| The People's Hospital of Zhalaite | Neimeng | China | Recruiting |
| Qingdao Municipal Hospital | Qingdao | China | Recruiting |
| Qilu Hospital of Shandong University | Shandong | China | Recruiting |
| Renji Hospital affiliated to Shanghai Jiaotong University | Shanghai | China | Recruiting |
| Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China | Recruiting |
| The People's Hospital of Liaoning Province | Shenyang | China | Recruiting |
| Shenzhen People's Hospital | Shenzhen | China | Recruiting |
| Suining County People's Hospital | Suining | China | Recruiting |
| Nanjing Drum Tower Hospital Group Suqian Hospital | Suqian | China | Recruiting |
| Suqian First Hospital | Suqian | China | Recruiting |
| Suzhou Dushu Lake Hospital | Suzhou | China | Recruiting |
| Suzhou Municipal Hospital of Anhui Province | Suzhou | China | Recruiting |
| Suzhou Municipal Hospital | Suzhou | China | Recruiting |
+ 21 more sites — see the full list on the official registry below.
More The First Affiliated Hospital with Nanjing Medical University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05410925 on ClinicalTrials.gov ↗ ← All trials in China