Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
OPTIMA-6
1 other identifier
interventional
2,260
1 country
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2023
Longer than P75 for phase_4
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 8, 2022
CompletedStudy Start
First participant enrolled
April 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
October 28, 2024
October 1, 2024
3.7 years
June 6, 2022
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE
Defined as a composite of all-cause death, reinfarction, unplanned target vessel revascularization, heart failure or cardiogenic shock, major ventricular arrhythmia
Within 90 days
Secondary Outcomes (12)
Each of the following cardiac and cerebrovascular events
Within 90 days
NT-proBNP
1 day before discharge or day 7, day 90±3
CMR indexes
Day 5
LVEF assessed by echocardiogram
Day 90±3
The percentage of TIMI flow grade 2 and 3 prior to PCI
Immediately prior to PCI
- +7 more secondary outcomes
Other Outcomes (4)
Major bleeding events during hospitalization or within 7 days (BARC 3, 5)
During hospitalization or within 7 days
Minor bleeding events during hospitalization or within 7 days (BARC 2)
During hospitalization or within 7 days
Major bleeding events within 90 days (BARC 3, 5)
Within 90 days
- +1 more other outcomes
Study Arms (2)
r-SAK group
EXPERIMENTALintravenous injection of single-bolus 5 mg r-SAK in 3 min
placebo group
PLACEBO COMPARATORintravenous injection of placebo in 3 min
Interventions
Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Intravenous injection of placebo is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
Eligibility Criteria
You may qualify if:
- Age 18-75 years, weight ≥45 kg
- Diagnosed as STEMI (meeting the following two conditions simultaneously)
- Ischemic chest pain lasts ≥ 30 minutes
- ECG indicates that ST-segment elevation of two or more contiguous precordial leads ≥ 0.1 mV, or ST-segment elevation of two or more contiguous precordial leads ≥ 0.2 mV
- Time from onset of persistent chest pain to randomization ≤12 hours
- Primary PCI expected to be performed ≥30 minutes, and ≤120 minutes
You may not qualify if:
- Cardiogenic shock
- Active bleeding or known at high risk of bleeding (including grade â…¢ or â…£ retinopathy or retinal gastrointestinal or urinary tract hemorrhage within the past 1 month)
- Ischemic stroke or TIA 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
- Puncture with difficult hemostasis by compression within 1 month (e.g., visceral biopsy, compartment puncture)
- Currently taking anticoagulants
- Poorly controlled hypertension ( ≥180/110 mmHg)
- Severe hepatic or renal impairment indicated by the consultation or previous history (glutamic-pyruvic transaminase or glutamic oxalacetic transaminase \>3 times upper limit of normal value; eGFR \<15 ml/min/1.73m\^2, calculated based on CKD-EPI)
- Known allergy to r-SAK
- Pregnancy, lactation, or planning for pregnancy
- History of chronic total occlusion, myocardial infarction or CABG
- Having taken antiplatelet drugs other than aspirin and ticagrelor, such as clopidogrel, prasugrel or cilostazol after the symptom onset
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, 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
Related Publications (18)
Gulati R, Behfar A, Narula J, Kanwar A, Lerman A, Cooper L, Singh M. Acute Myocardial Infarction in Young Individuals. Mayo Clin Proc. 2020 Jan;95(1):136-156. doi: 10.1016/j.mayocp.2019.05.001.
PMID: 31902409BACKGROUNDBahit MC, Kochar A, Granger CB. Post-Myocardial Infarction Heart Failure. JACC Heart Fail. 2018 Mar;6(3):179-186. doi: 10.1016/j.jchf.2017.09.015.
PMID: 29496021BACKGROUNDHeusch G, Libby P, Gersh B, Yellon D, Bohm M, Lopaschuk G, Opie L. Cardiovascular remodelling in coronary artery disease and heart failure. Lancet. 2014 May 31;383(9932):1933-43. doi: 10.1016/S0140-6736(14)60107-0. Epub 2014 May 13.
PMID: 24831770BACKGROUNDJuilliere Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Meneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol (Engl Ed). 2012 Apr;65(4):326-33. doi: 10.1016/j.recesp.2011.10.027. Epub 2012 Feb 20.
PMID: 22357361BACKGROUNDBradley EH, Nallamothu BK, Herrin J, Ting HH, Stern AF, Nembhard IM, Yuan CT, Green JC, Kline-Rogers E, Wang Y, Curtis JP, Webster TR, Masoudi FA, Fonarow GC, Brush JE Jr, Krumholz HM. National efforts to improve door-to-balloon time results from the Door-to-Balloon Alliance. J Am Coll Cardiol. 2009 Dec 15;54(25):2423-9. doi: 10.1016/j.jacc.2009.11.003.
PMID: 20082933BACKGROUNDMangin L, Lotfi M, Puie P, Yayehd K, Ispas A, Belle L. [Management of high thrombus burden in primary PCI]. Ann Cardiol Angeiol (Paris). 2017 Dec;66(6):380-384. doi: 10.1016/j.ancard.2017.10.016. Epub 2017 Oct 31. French.
PMID: 29096903BACKGROUNDBai M, Pan CL, Zhao J, Zhao CR, Zhang B, Mu ZY, Meng XX, Zhou XH, Zhu YQ, Zhang Z. [Safety and efficacy of regional transport combined with PCI model in patients with STEMI after thrombolysis in northwest China]. Zhonghua Xin Xue Guan Bing Za Zhi. 2020 Aug 24;48(8):641-647. doi: 10.3760/cma.j.cn112148-20200228-00138. Chinese.
PMID: 32847319BACKGROUNDSchwartz R, Weiss AT, Leibowitz D, Rot D, Pollak A, Lotan C, Alcalai R. Thrombolysis followed by coronary angiography versus primary percutaneous coronary intervention in non-anterior ST-elevation myocardial infarction. J Invasive Cardiol. 2013 Dec;25(12):632-6.
PMID: 24296382BACKGROUNDRen K, Gong H, Huang J, Liu Y, Dong Q, He K, Tian L, Zhang F, Yu A, Wu C. Thrombolytic and anticoagulant effects of a recombinant staphylokinase-hirudin fusion protein. Thromb Res. 2021 Dec;208:26-34. doi: 10.1016/j.thromres.2021.10.005. Epub 2021 Oct 14.
PMID: 34688099BACKGROUNDVanderschueren S. [Staphylokinase for a better thrombolytic treatment of heart and platelet diseases]. Verh K Acad Geneeskd Belg. 2000;62(1):69-75. Dutch.
PMID: 10769618BACKGROUNDUeshima S, Matsuo O. Development of new fibrinolytic agents. Curr Pharm Des. 2006;12(7):849-57. doi: 10.2174/138161206776056065.
PMID: 16515501BACKGROUNDYamamoto J, Kawano M, Hashimoto M, Sasaki Y, Yamashita T, Taka T, Watanabe S, Giddings JC. Adjuvant effect of antibodies against von Willebrand Factor, fibrinogen, and fibronectin on staphylokinase-induced thrombolysis as measured using mural thrombi formed in rat mesenteric venules. Thromb Res. 2000 Mar 1;97(5):327-33. doi: 10.1016/s0049-3848(99)00184-x.
PMID: 10709908BACKGROUNDSzemraj J, Stankiewicz A, Rozmyslowicz-Szerminska W, Mogielnicki A, Gromotowicz A, Buczko W, Oszajca K, Bartkowiak J, Chabielska E. A new recombinant thrombolytic and antithrombotic agent with higher fibrin affinity - a staphylokinase variant. An in-vivo study. Thromb Haemost. 2007 Jun;97(6):1037-45. doi: 10.1160/th06-10-0562.
PMID: 17549308BACKGROUNDVakili B, Nezafat N, Negahdaripour M, Yari M, Zare B, Ghasemi Y. Staphylokinase Enzyme: An Overview of Structure, Function and Engineered Forms. Curr Pharm Biotechnol. 2017;18(13):1026-1037. doi: 10.2174/1389201019666180209121323.
PMID: 29424308BACKGROUNDLi CJ, Huang J, Yang ZJ, Cao KJ. Thrombolytic efficacy of native recombinant staphylokinase on femoral artery thrombus of rabbits. Acta Pharmacol Sin. 2007 Jan;28(1):58-65. doi: 10.1111/j.1745-7254.2007.00455.x.
PMID: 17184583BACKGROUNDNedaeinia R, Faraji H, Javanmard SH, Ferns GA, Ghayour-Mobarhan M, Goli M, Mashkani B, Nedaeinia M, Haghighi MHH, Ranjbar M. Bacterial staphylokinase as a promising third-generation drug in the treatment for vascular occlusion. Mol Biol Rep. 2020 Jan;47(1):819-841. doi: 10.1007/s11033-019-05167-x. Epub 2019 Nov 1.
PMID: 31677034BACKGROUNDVanderschueren S, Barrios L, Kerdsinchai P, Van den Heuvel P, Hermans L, Vrolix M, De Man F, Benit E, Muyldermans L, Collen D, et al. A randomized trial of recombinant staphylokinase versus alteplase for coronary artery patency in acute myocardial infarction. The STAR Trial Group. Circulation. 1995 Oct 15;92(8):2044-9. doi: 10.1161/01.cir.92.8.2044.
PMID: 7554180BACKGROUNDArmstrong PW, Burton J, Pakola S, Molhoek PG, Betriu A, Tendera M, Bode C, Adgey AA, Bar F, Vahanian A, Van de Werf F; CAPTORS II Investigators. Collaborative Angiographic Patency Trial Of Recombinant Staphylokinase (CAPTORS II). Am Heart J. 2003 Sep;146(3):484-8. doi: 10.1016/S0002-8703(03)00312-0.
PMID: 12947367BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunjian Li, PHD
The First Affiliated Hospital with Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cardiology
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 8, 2022
Study Start
April 8, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
October 28, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share