Acute Myocardial Infarction in Young Individuals.
Rajiv Gulati, Atta Behfar, Jagat Narula...
https://pubmed.ncbi.nlm.nih.gov/31902409Actively Recruiting
Phase 4
Age: 18Years - 75Years
All Genders
ID05410925
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)
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-10-28
2260
Participants Needed
61
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding a half-dose bolus of recombinant staphylokinase (r-SAK), a clot-dissolving drug, immediately before primary percutaneous coronary intervention (PCI) can improve outcomes in patients with acute ST-segment elevation myocardial infarction (STEMI) treated within 120 minutes. This randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of r-SAK in reducing major adverse cardiovascular events within 90 days after treatment. Participants are randomly assigned to receive either a single intravenous bolus of 5 mg r-SAK over 3 minutes or a placebo injection within 10 minutes after STEMI diagnosis. Following this, all patients undergo primary PCI within 30 to 120 minutes. The study is conducted across multiple centers and compares the effects of r-SAK versus placebo as adjunctive therapy before PCI. During the study, participants will be monitored for major adverse cardiovascular events up to 90 days, with additional assessments including cardiac and cerebrovascular events, blood biomarkers (NT-proBNP), cardiac imaging by echocardiogram and cardiac magnetic resonance imaging (CMR), and blood flow in coronary arteries immediately before and after PCI. Safety and efficacy will also be tracked up to one year. The total participation duration includes follow-up visits at days 7, 90, and 360 after treatment.
CONDITIONS
Brief Title
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years and weight at least 45 kg
- Diagnosed with STEMI with chest pain lasting 30 minutes or more
- ECG shows ST-segment elevation in two or more contiguous leads (≥0.1 mV in precordial leads or ≥0.2 mV in other leads)
- Time from onset of chest pain to randomization is 12 hours or less
- Primary PCI expected to be performed within 30 to 120 minutes
You will not qualify if you...
- Cardiogenic shock
- Active bleeding or high risk of bleeding, including recent severe retinal, gastrointestinal, or urinary tract hemorrhage within the past month
- Ischemic stroke or transient ischemic attack in the past 6 months
- History of hemorrhagic stroke
- Known intracranial aneurysm
- Severe trauma, surgery, or head injury within 1 month
- Suspected aortic dissection or infective endocarditis
- Recent puncture with difficult hemostasis within 1 month
- Currently taking anticoagulants
- Poorly controlled high blood pressure (≥180/110 mmHg)
- Severe liver or kidney impairment
- Known allergy to r-SAK
- Pregnancy, breastfeeding, or planning pregnancy
- History of chronic total occlusion, myocardial infarction, or coronary artery bypass grafting
- Use of antiplatelet drugs other than aspirin and ticagrelor after symptom onset
- Any other condition that makes participation unsuitable according to investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 12 hours from chest pain onset
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - From injection until completion of primary PCI, within 30 to 120 minutes
Participants receive a single intravenous bolus injection of either half-dose r-SAK or placebo prior to undergoing primary PCI within 30 to 120 minutes after randomization.
1 treatment visit (in-person)
Follow-up
Duration - Up to 360 days after treatment
Participants are followed for safety and efficacy outcomes including cardiac events, biomarkers, and imaging assessments.
Multiple visits including assessments at day 5, day 7 or before discharge, day 90, and day 360
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
Actively Recruiting
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
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Research Team
C
Chunjian Li, PHD
C
Chen Li, MD
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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