Actively Recruiting
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-10-28
2260
Participants Needed
61
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years and weigh at least 45 kg
- Diagnosed with STEMI showing ischemic chest pain lasting 30 minutes or more
- ECG evidence of ST-segment elevation in two or more contiguous precordial leads (≥ 0.1 mV or ≥ 0.2 mV)
- Time from chest pain onset to randomization is 12 hours or less
- Primary PCI expected to be performed between 30 and 120 minutes after diagnosis
You will not qualify if you...
- Cardiogenic shock
- Active bleeding or high bleeding risk including recent serious bleeding in the past month
- Ischemic stroke or transient ischemic attack within the past 6 months
- History of hemorrhagic stroke
- Known intracranial aneurysm
- Severe trauma, surgery, or head injury within the past month
- Suspected aortic dissection or infective endocarditis
- Difficult to stop bleeding after recent puncture within the past month
- Currently taking anticoagulant medications
- Poorly controlled high blood pressure (≥ 180/110 mmHg)
- Severe liver or kidney problems
- Known allergy to recombinant staphylokinase
- Pregnancy, breastfeeding, or planning pregnancy
- History of chronic total occlusion, previous myocardial infarction, or coronary artery bypass grafting
- Use of antiplatelet drugs other than aspirin and ticagrelor after symptom onset
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 61 locations
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
2
Changzhou Second People's Hospital
Changzhou, China
Actively Recruiting
3
Changzhou Wujin People's Hospital
Changzhou, China
Actively Recruiting
4
The First People's Hospital of Changzhou
Changzhou, China
Actively Recruiting
5
Chongqing Hospital of Jiangsu Province Hospital
Chongqing, China
Actively Recruiting
6
The second Affiliated Hospital of Dalian Medical University
Dalian, China
Actively Recruiting
7
Daqing Oilfield General Hospital
Daqing, China
Actively Recruiting
8
Dongguan People's Hospital
Dongguan, China
Actively Recruiting
9
Fengcheng People's Hospital
Fengcheng, China
Actively Recruiting
10
General Hospital of Southern Theatre Command
Guangzhou, China
Actively Recruiting
11
The Second Affiliated Hospital of Hainan Medical University
Hainan, China
Actively Recruiting
12
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China
Actively Recruiting
13
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, China
Actively Recruiting
14
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
15
Huai'an First People's Hospital
Huai'an, China
Actively Recruiting
16
Huai'an Second People's Hospital
Huai'an, China
Actively Recruiting
17
Donghai Country People's Hospital
Lianyungang, China
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18
The First People's Hospital of Lianyungang
Lianyungang, China
Actively Recruiting
19
The Second People's Hospital of Lianyungang
Lianyungang, China
Actively Recruiting
20
Liyang Hospital of Jiangsu Province Hospital
Liyang, China
Actively Recruiting
21
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
22
Nanjing Tongren Hospital
Nanjing, China
Actively Recruiting
23
Sir Run Run Hospital Nanjing Medical University
Nanjing, China
Actively Recruiting
24
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
25
Nanjing Qixia District Hospital
Nanning, China
Actively Recruiting
26
Affiliated Hospital of Nantong University
Nantong, China
Actively Recruiting
27
Nantong First People's Hospital
Nantong, China
Actively Recruiting
28
The People's Hospital of Zhalaite
Neimeng, China
Actively Recruiting
29
Qingdao Municipal Hospital
Qingdao, China
Actively Recruiting
30
Qilu Hospital of Shandong University
Shandong, China
Actively Recruiting
31
Renji Hospital affiliated to Shanghai Jiaotong University
Shanghai, China
Actively Recruiting
32
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
33
The People's Hospital of Liaoning Province
Shenyang, China
Actively Recruiting
34
Shenzhen People's Hospital
Shenzhen, China
Actively Recruiting
35
Suining County People's Hospital
Suining, China
Actively Recruiting
36
Nanjing Drum Tower Hospital Group Suqian Hospital
Suqian, China
Actively Recruiting
37
Suqian First Hospital
Suqian, China
Actively Recruiting
38
Suzhou Dushu Lake Hospital
Suzhou, China
Actively Recruiting
39
Suzhou Municipal Hospital of Anhui Province
Suzhou, China
Actively Recruiting
40
Suzhou Municipal Hospital
Suzhou, China
Actively Recruiting
41
The First Affiliated Hospital of Soochow University
Suzhou, China
Actively Recruiting
42
Wanbei Coal-Electricity Group General Hospital
Suzhou, China
Actively Recruiting
43
Taihe County Traditional Chinese Medicine Hospital
Taihe, China
Actively Recruiting
44
Taishan People's Hospital
Taishan, China
Actively Recruiting
45
Taizhou People's Hospital
Taizhou, China
Actively Recruiting
46
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
47
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Actively Recruiting
48
Affiliated Hospital of Jiangnan University
Wuxi, China
Actively Recruiting
49
Wuxi People's Hospital
Wuxi, China
Actively Recruiting
50
Wuxi Second People's Hospital
Wuxi, China
Actively Recruiting
51
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Actively Recruiting
52
The People's Hospital of Jiawang District of Xuzhou City
Xuzhou, China
Actively Recruiting
53
Xuzhou Central Hospital
Xuzhou, China
Actively Recruiting
54
Yancheng No.1 People's Hospital
Yancheng, China
Actively Recruiting
55
Affiliated Hospital of Yangzhou University
Yangzhou, China
Actively Recruiting
56
Subei People's Hospital of Jiangsu province
Yangzhou, China
Actively Recruiting
57
Fuwai Central China Cardiovascular Hospital
Zhengzhou, China
Actively Recruiting
58
The 7th People's Hospital of Zhengzhou
Zhengzhou, China
Actively Recruiting
59
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
60
Affiliated Hospital of Jiangsu University
Zhenjiang, China
Actively Recruiting
61
Zhenjiang First People's Hospital
Zhenjiang, China
Actively Recruiting
Research Team
C
Chunjian Li, PHD
CONTACT
C
Chen Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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