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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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.

Pengcheng He, MD contact

86-13829730152

drhepengcheng@aliyun.com

50 sites in 1 country

China50 sites, 50 recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 13787318063

    Yu Cao, MD, 13787318063, 13787318063@139.com

    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

    Not yet 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

    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

    Not yet 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

    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

    Not yet 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

    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

    Not yet 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

    Recruiting

  • Shaoxing people's Hospital

    Shaoxing, Zhejiang, 312000

    Yangjian Liu, 13570786812

    Not yet 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

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518035

    Chun Wu, MM, 13923748673, 2508257466@qq.com

    Not yet 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

    Recruiting

  • The First Affilicated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Yining Yang, MD, 13199860611

    Not yet recruiting

  • Affiliated Hospital, Weifang Medical University

    Weifang, Shandong, 261031

    Jingtian Li

    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

    Not yet 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

    Recruiting

  • The Second Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

    Can Chen, 13902502296

    Not yet recruiting

  • Sihui people's Hospital

    Zhaoqing, Guangdong, 526200

    Yuehua Huang, 13929832932

    Recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong, 528403

    Li Feng

    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

    Not yet recruiting

Other trials in China

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 groups in NCT04212494
Study groupRoleWhat they receive
Thrombus aspirationExperimentalUpfront manual thrombus aspiration followed by PCI
Receives: Procedure: Thrombus aspiration
PCI AloneActive comparatorPCI 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.

  1. 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)

  1. 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

  2. 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.

  1. First posted27 Dec 2019
  2. Study start30 Aug 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

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)
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 6350634

  • DeWood 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 7412821

  • Sianos 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 17692740

  • Beran 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 12021220

  • Burzotta 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 16022970

  • Vlaar 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 18539223

  • Frobert 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 23991656

  • Jolly 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 25853743

  • Levine 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 26498666

  • Jolly 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 27941066

  • Ibanez 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pengcheng He, MD (86-13829730152, drhepengcheng@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse cardiovascular events (time frame: up to180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04212494, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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