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NCT Number: NCT04212494

Thrombus Aspiration in 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.

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Key information

Conditions

ST-segment Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Provincial Hospital, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

Thrombus Aspiration

Procedure

Percutaneous Coronary Intervention with manual aspiration thrombectomy

PCI Alone

Procedure

Percutaneous Coronary Intervention without manual aspiration thrombectomy

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: up to180 days

    The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization

Secondary outcomes

  1. Stroke

    Time frame: up to 30 days

    The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular

  2. Composite adverse cardiocerebrovascular events

    Time frame: up to 1 year

    The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke.

Study contacts

Contact information is provided by the study sponsor or research team.

Pengchen He, MD

CONTACT

[email protected]

86-13829730152

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • Bobai County People's Hospital, Guangxi
  • Chen Zhou 3RD People's Hospital
  • Dafeng Hospital of Chaoyang District in Shantou City
  • Dongguan People's Hospital
  • Eighth Affiliated Hospital, Sun Yat-sen University
  • First People's Hospital of Foshan
  • Foshan Sanshui District People's Hospital
  • Guangning People's Hospital
  • Guangxi Zhuang Autonomous Region Nationalities Hospital
  • Guangzhou Hospital of integrated Traditional and West Medicine
  • Heyuan people's Hospital
  • Huaiji People's Hospital
  • Jiangmen Central Hospital
  • Kaiping Central Hospital
  • Lianping Xian Ren Ming Yi Yuan
  • Lianzhou People's Hospital
  • Liuzhou Municipal Liutie Central Hospital
  • Longgang District People's Hospital of Shenzhen
  • Luhe County People's Hospital
  • Meizhou Traditional Chinese Medicine Hospital
  • Nanning Second People's Hospital
  • People's Hospital of Dapu County
  • People's Hospital of Nanhai District, Foshan
  • People's Hospital of Nanxiong County
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • People's Hospital of Yingde City
  • Qingyuan People's Hospital
  • Second Affiliated Hospital of Shantou University Medical College
  • Shangyou People's Hospital
  • Shantou Central Hospital
  • Shenzhen Baoan District People's Hospital
  • Shenzhen Longhua District Central Hospital
  • Shenzhen People's Hospital
  • Shenzhen Third People's Hospital
  • Sihui City People's Hospital
  • Taishan People's Hospital
  • The Affiliated Shunde Hospital of Jinan University
  • The First People's Hospital of Kashgar Erea
  • The Fourth People's Hospital of Chenzhou
  • The Second Affiliated Hospital of Dalian Medical University
  • The Second People's Hospital of Foshan
  • The Second People's Hospital of Nanhai District of Foshan
  • The Third Affiliated Hospital of Guangzhou Medical University
  • The Third Affiliated Hospital of Sun Yat-Sen University, Yuedong Hospital
  • The Third Xiangya Hospital of Central South University
  • Tongxiang First People's Hospital
  • Weifang Medical University
  • Wuzhou Gongren Hospital
  • Yangchun People's Hospital
  • Yangjiang People's Hospital
  • Yuebei People's Hospital
  • Zhaoqing Gaoyao People's Hospital
  • Zhongshan Hospital Of Traditional Chinese Medicine
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Official study title

Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Dec 27, 2019
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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