ST-segment Elevation Myocardial Infarction (STEMI)NCT04212494
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
A study testing Thrombus aspiration and PCI Alone in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Guangdong Provincial People's Hospital at 50 sites in China.
Trial summary
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Thrombus aspiration and PCI Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,838 participants
- Where
- 50 sitesChina
- Study dates
- 30 Aug 2020to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
- High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
- Informed consent must be voluntary;
Who cannot join
- Haemodynamic instability or cardiogenic shock;
- After thrombolytic therapy;
- The predicted survival time is less than 6 months due to non-cardiac disease;
- History of coronary artery bypass grafting;
- Participate in other researches within 30 days;
- Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
- Patients were considered unsuitable by other researchers.
Trial locations and contacts
50 sites in 1 country. Contact the study team or a site near you to ask about taking part.
50 sites in 1 country
China50 sites, 50 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 13787318063
Yu Cao, MD, 13787318063, 13787318063@139.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Xinqun Hu, MD, 13307313627, huxinqungs@163.com
- Not yet recruiting
West China Hospital
Chengdu, Sichuan, 610041
Yong He, MD, 18980602038, happensky@163.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Jianhong Tao, 18981838875, taojianhong06@medmail.com
- Recruiting
First People's Hospital of Foshan
Foshan, Guangdong, 528000
Xili Yang, 18038863836, Yannihu@126.com
- Recruiting
The Second People's Hospital of Nanhai District
Foshan, Guangdong, 528251
Pengcheng He, MD, 13829730152, drhepengcheng@aliyun.com
- Recruiting
First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)
Foshan, Guangdong, 528300
Yunzhao Hu, 13702832088
- Not yet recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Wei Chen, 13950394772, hpscw@sina.com
- Not yet recruiting
GanZhou Municopal Hospital
Ganzhou, Jiangxi, 341000
Zhonghan Ni, 13889908239
- Recruiting
Shangyou Hospital
Ganzhou, Jiangxi, 341200
Shuo Sun, 15018788144
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000
Pengcheng He, MD, 86-13829730152, drhepengcheng@aliyun.com
- Not yet recruiting
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 510000
Jianhao Li, 13928838806
- Not yet recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
Dingcheng Xiang, MD, 13609008024, dcxiang@foxmail.com
- Not yet recruiting
The first Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Yi Li, MD, 13822285813
- Not yet recruiting
Guangdong Provincial Hospital of traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Xia Wang, 13825133223
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Zheng Huang, MD, 13802503802, 13802503802@163.com
- Not yet recruiting
The Second Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510235
Ruqiong Nie
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Hua Xiao, 13889900264
- Not yet recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Jianping Bin, MD, 18680488488
- Not yet recruiting
Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510700
Qing Xu, 13609648852
- Not yet recruiting
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, 510800
Junhui Xiao, 15011888377
- Not yet recruiting
Guilin people's Hospital
Guilin, Guangxi, 541002
Bin Li, 18978320601
- Not yet recruiting
The Second Clinical College of Hainan Medical University
Haikou, Hainan, 460106
Yuewu Chen, 13518085982, 576157175@qq.com
- Not yet recruiting
Hainan People's Hospital
Haikou, Hainan, 570311
Bin Li, 13907698311
- Not yet recruiting
Huizhou Third People's Hospital
Huizhou, Guangdong, 516002
Sigan Zhong, 13502428918
- Recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030
Gaoxing Zhang, MD, 13322889844, 5886970@qq.com
- Recruiting
Kaiping Central Hospital
Kaiping, Guangdong, 529300
- Recruiting
Kashgar first people's Hospital
Kashgar, Xinjiang, 844000
Yuying Hu, 13579061010
- Not yet recruiting
Yan'an Hospital of Kunming City
Kunming, Yunnan, 65005
Qiang Xue, MD
- Not yet recruiting
Maoming People's Hospital
Maoming, Guangdong, 525000
Chunbo Chen, MD, 13922745788
- Recruiting
The Second Affiliated Hospital of Shantou university Medical College
Shantou, Guangdong, 515041
Jilin Li, MD, 13592852807
- Recruiting
Yue Bei People's Hospital
Shaoguan, Guangdong, 512026
Liangqiu Tang, 13509056589
- Not yet recruiting
Shaoxing people's Hospital
Shaoxing, Zhejiang, 312000
Yangjian Liu, 13570786812
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Huadong Liu, MD, 13724397998, lhd2578@163.com
- Recruiting
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, 518033
Guifu Wu, PD, 15989893111
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518035
Chun Wu, MM, 13923748673, 2508257466@qq.com
- Recruiting
Shenzhen Bao'an District People's Hospital
Shenzhen, Guangdong, 518101
Zhiming Shen, 13632772238
- Recruiting
Taishan people's Hospital
Taishan, Guangdong, 529200
Yan Chen, 13580014030
- Not yet recruiting
The First Affilicated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Yining Yang, MD, 13199860611
- Recruiting
Affiliated Hospital, Weifang Medical University
Weifang, Shandong, 261031
Jingtian Li
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Hao Zhou
- Not yet recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Hua Yan, MD, 13100659066, Yanhua0807@aliyun.com
- Not yet recruiting
The first Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Ning Guo, 13991229101
- Recruiting
Nanxiong people's Hospital
Xiongzhou, Guangdong, 512400
Foyuan Fan, 15914844979
- Recruiting
People's Hospital of Yangjiang City
Yangjiang, Guangdong, 529500
Jiaman Ou, 13829810048, 297122698@qq.com
- Not yet recruiting
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
Can Chen, 13902502296
- Recruiting
Sihui people's Hospital
Zhaoqing, Guangdong, 526200
Yuehua Huang, 13929832932
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Li Feng
- Not yet recruiting
The Fifth Affiliated Hospital, Sun Yat-Sen University
Zhuhai, Guangdong, 519000
Jian Chen, MD, 13926931713, chenjn@mail.sysu.edu.cn
- Not yet recruiting
Zhuhai people's Hospital
Zhuhai, Guangdong, 519000
Jun Li, 13709686461
About this study
Official title: Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.
Read the detailed description
This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.
- Being tested
- Thrombus aspiration, PCI Alone
- Keywords
- Thrombus Aspiration, Coronary Intervention, Thrombus Burden, ST-segment Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombus aspirationProcedure or surgery
Percutaneous Coronary Intervention with manual aspiration thrombectomy
PCI AloneProcedure or surgery
Percutaneous Coronary Intervention without manual aspiration thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Thrombus aspiration | Experimental | Upfront manual thrombus aspiration followed by PCI Receives: Procedure: Thrombus aspiration |
| PCI Alone | Active comparator | PCI without upfront manual thrombus aspiration Receives: Procedure: PCI Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization
Measured: up to180 days
Secondary outcomes (2)
Stroke
The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular
Measured: up to 30 days
Composite adverse cardiocerebrovascular events
The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start30 Aug 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,838 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan People's Hospital, Guangdong, China, Kaiping Central Hospital, Second Affiliated Hospital of Shantou University Medical College, The Third Xiangya Hospital of Central South University, Sihui City People's Hospital, Shenzhen Baoan District People's Hospital, People's Hospital of Nanxiong County, Yuebei People's Hospital, Weifang Medical University, Wuzhou Gongren Hospital, Dafeng Hospital of Chaoyang District in Shantou City, Dongguan People's Hospital, Yangchun People's Hospital, Taishan People's Hospital, The Second People's Hospital of Foshan, Guangzhou Hospital of integrated Traditional and West Medicine, Guangning People's Hospital, Foshan Sanshui District People's Hospital, Qingyuan People's Hospital, Luhe County People's Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, The Fourth People's Hospital of Chenzhou, People's Hospital of Dapu County, Shenzhen People's Hospital, Heyuan Shenhe People's Hospital, Huaiji People's Hospital, People's Hospital of Yingde City, Zhongshan Hospital Of Traditional Chinese Medicine, The Third Affiliated Hospital of Guangzhou Medical University, Lianzhou People's Hospital, Lianping Xian Ren Ming Yi Yuan, Guangxi Zhuang Autonomous Region Nationalities Hospital, Liuzhou Municipal Liutie Central Hospital, Chen Zhou 3RD People's Hospital, Longgang District People's Hospital of Shenzhen, The Affiliated Shunde Hospital of Jinan University, Shenzhen Longhua District Central Hospital, Shantou Central Hospital, Tongxiang First People's Hospital, Bobai County People's Hospital, Guangxi, Meizhou Traditional Chinese Medicine Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Shenzhen Third People's Hospital, Yangjiang People's Hospital, Jiangmen Central Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, The First People's Hospital of Kashgar Erea, First People's Hospital of Foshan, Zhaoqing Gaoyao People's Hospital, Nanhai District People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Nanning Second People's Hospital, The Second People's Hospital of Nanhai District of Foshan, Shangyou People's Hospital, Southern Medical University, China, Chaozhou Central Hospital, Chaoshan Hospital, the First Affiliated Hospital of Jinan University, Shenzhen Baoan District Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Gannan Medical College, Puyang People's Hospital, Tongliao People's Hospital, Luohe Central Hospital, Linying County People's Hospital, Xiaolan People's Hospital of Zhongshan, The First Dongguan Affiliated Hospital of Guangdong Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212494
- Sponsor's protocol ID
- GDREC2018404H(R2)
- Status last verified
- Sep 2026
- First submitted
- 24 Dec 2019
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrick JB. Landmark article (JAMA 1912). Clinical features of sudden obstruction of the coronary arteries. By James B. Herrick. JAMA. 1983 Oct 7;250(13):1757-65. No abstract available.
PubMed 6350634DeWood MA, Spores J, Notske R, Mouser LT, Burroughs R, Golden MS, Lang HT. Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. N Engl J Med. 1980 Oct 16;303(16):897-902. doi: 10.1056/NEJM198010163031601.
PubMed 7412821Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.
PubMed 17692740Beran G, Lang I, Schreiber W, Denk S, Stefenelli T, Syeda B, Maurer G, Glogar D, Siostrzonek P. Intracoronary thrombectomy with the X-sizer catheter system improves epicardial flow and accelerates ST-segment resolution in patients with acute coronary syndrome: a prospective, randomized, controlled study. Circulation. 2002 May 21;105(20):2355-60. doi: 10.1161/01.cir.0000016350.02669.1d.
PubMed 12021220Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6. doi: 10.1016/j.jacc.2005.04.057.
PubMed 16022970Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.
PubMed 18539223Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31.
PubMed 23991656Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
PubMed 25853743Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available.
PubMed 26498666Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9.
PubMed 27941066Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621