Thrombus Aspiration in STEMI Patients With High Thrombus Burden

September 14, 2023 updated by: Guangdong Provincial People's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3838

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Provincial Hospital
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Not yet recruiting
        • First People's Hospital of Foshan
        • Contact:
      • Foshan, Guangdong, China, 528251
        • Recruiting
        • The Second People's Hospital of Nanhai District
        • Contact:
      • Foshan, Guangdong, China, 528300
        • Not yet recruiting
        • First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)
        • Contact:
          • Yunzhao Hu
          • Phone Number: 13702832088
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital
        • Contact:
          • Jianping Bin, MD
          • Phone Number: 18680488488
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Yi Li, MD
          • Phone Number: 13822285813
      • Guangzhou, Guangdong, China, 510280
        • Not yet recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
          • Hua Xiao
          • Phone Number: 13889900264
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Guangzhou Panyu Central Hospital
        • Contact:
          • Jianhao Li
          • Phone Number: 13928838806
      • Guangzhou, Guangdong, China, 510010
        • Not yet recruiting
        • Guangzhou General Hospital of Guangzhou Military Command
        • Contact:
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Xia Wang
          • Phone Number: 13825133223
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510235
        • Not yet recruiting
        • The Second Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Ruqiong Nie
      • Guangzhou, Guangdong, China, 510700
        • Not yet recruiting
        • Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Qing Xu
          • Phone Number: 13609648852
      • Guangzhou, Guangdong, China, 510800
        • Not yet recruiting
        • Huadu District People's Hospital of Guangzhou
        • Contact:
          • Junhui Xiao
          • Phone Number: 15011888377
      • Huizhou, Guangdong, China, 516002
        • Not yet recruiting
        • Huizhou Third People's Hospital
        • Contact:
          • Sigan Zhong
          • Phone Number: 13502428918
      • Jiangmen, Guangdong, China, 529030
        • Not yet recruiting
        • Jiangmen Central Hospital
        • Contact:
      • Kaiping, Guangdong, China, 529300
        • Recruiting
        • Kaiping Central Hospital
      • Maoming, Guangdong, China, 525000
        • Not yet recruiting
        • Maoming People's Hospital
        • Contact:
          • Chunbo Chen, MD
          • Phone Number: 13922745788
      • Nanxiong, Guangdong, China, 512400
        • Not yet recruiting
        • Nanxiong people's Hospital
        • Contact:
          • Foyuan Fan
          • Phone Number: 15914844979
      • Shantou, Guangdong, China, 515041
        • Recruiting
        • The Second Affiliated Hospital of Shantou University Medical College
        • Contact:
          • Jilin Li, MD
          • Phone Number: 13592852807
      • Shaoguan, Guangdong, China, 512026
        • Not yet recruiting
        • Yue Bei People's Hospital
        • Contact:
          • Liangqiu Tang
          • Phone Number: 13509056589
      • Shenzhen, Guangdong, China, 518020
        • Not yet recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518035
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518033
        • Not yet recruiting
        • The Eighth Affiliated Hospital, Sun Yat-Sen University
        • Contact:
          • Guifu Wu, PD
          • Phone Number: 15989893111
      • Shenzhen, Guangdong, China, 518101
        • Not yet recruiting
        • Shenzhen Bao'an District People's Hospital
        • Contact:
          • Zhiming Shen
          • Phone Number: 13632772238
      • Taishan, Guangdong, China, 529200
        • Not yet recruiting
        • Taishan people's hospital
        • Contact:
          • Yan Chen
          • Phone Number: 13580014030
      • Yangjiang, Guangdong, China, 529500
        • Recruiting
        • People's Hospital of Yangjiang City
        • Contact:
      • Zhanjiang, Guangdong, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Can Chen
          • Phone Number: 13902502296
      • Zhaoqing, Guangdong, China, 526200
        • Recruiting
        • Sihui people's Hospital
        • Contact:
          • Yuehua Huang
          • Phone Number: 13929832932
      • Zhongshan, Guangdong, China, 528403
        • Not yet recruiting
        • Zhongshan People's Hospital
        • Contact:
          • Li Feng
      • Zhuhai, Guangdong, China, 519000
        • Not yet recruiting
        • The Fifth Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Zhuhai, Guangdong, China, 519000
        • Not yet recruiting
        • Zhuhai People's Hospital
        • Contact:
          • Jun Li
          • Phone Number: 13709686461
    • Guangxi
      • Guilin, Guangxi, China, 541002
        • Not yet recruiting
        • Guilin People's Hospital
        • Contact:
          • Bin Li
          • Phone Number: 18978320601
    • Hainan
      • Haikou, Hainan, China, 460106
        • Not yet recruiting
        • The Second Clinical College of Hainan Medical University
        • Contact:
      • Haikou, Hainan, China, 570311
        • Not yet recruiting
        • Hainan People's Hospital
        • Contact:
          • Bin Li
          • Phone Number: 13907698311
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Wuhan Asia Heart Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 13787318063
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410008
        • Not yet recruiting
        • The second Xiangya Hospital of Central South University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Not yet recruiting
        • GanZhou Municopal Hospital
        • Contact:
          • Zhonghan Ni
          • Phone Number: 13889908239
      • Ganzhou, Jiangxi, China, 341200
        • Not yet recruiting
        • Shangyou Hospital
        • Contact:
          • Shuo Sun
          • Phone Number: 15018788144
    • Shandong
      • Weifang, Shandong, China, 261031
        • Not yet recruiting
        • Affiliated Hospital, Weifang Medical University
        • Contact:
          • Jingtian Li
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Ning Guo
          • Phone Number: 13991229101
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital
        • Contact:
    • Xinjiang
      • Kashgar, Xinjiang, China, 844000
        • Not yet recruiting
        • Kashgar First People's Hospital
        • Contact:
          • Yuying Hu
          • Phone Number: 13579061010
      • Urumqi, Xinjiang, China, 830054
        • Not yet recruiting
        • The First Affilicated Hospital of Xinjiang Medical University
        • Contact:
          • Yining Yang, MD
          • Phone Number: 13199860611
    • Yunnan
      • Kunming, Yunnan, China, 65005
        • Not yet recruiting
        • Yan'an Hospital of Kunming City
        • Contact:
          • Qiang Xue, MD
    • Zhejiang
      • Shaoxing, Zhejiang, China, 312000
        • Not yet recruiting
        • Shaoxing People's Hospital
        • Contact:
          • Yangjian Liu
          • Phone Number: 13570786812
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hao Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years;
  2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
  3. High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
  4. Informed consent must be voluntary;

Exclusion Criteria:

  1. Haemodynamic instability or cardiogenic shock;
  2. After thrombolytic therapy;
  3. The predicted survival time is less than 6 months due to non-cardiac disease;
  4. History of coronary artery bypass grafting;
  5. Participate in other researches within 30 days;
  6. Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
  7. Patients were considered unsuitable by other researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrombus aspiration
Upfront manual thrombus aspiration followed by PCI
Procedure: Thrombus aspiration
Percutaneous Coronary Intervention with manual aspiration thrombectomy
Active Comparator: PCI Alone
PCI without upfront manual thrombus aspiration
Procedure: PCI Alone
Percutaneous Coronary Intervention without manual aspiration thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: up to180 days
The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization
up to180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days
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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Collaborators

West China Hospital
Shenzhen People's Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Central South University
First People's Hospital of Foshan
Peking University Shenzhen Hospital
Wuhan Asia Heart Hospital
Sichuan Provincial People's Hospital
Fujian Provincial Hospital
ZhuHai Hospital
Jiangmen Central Hospital
Hainan People's Hospital
First Affiliated Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2020

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

December 24, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDREC2018404H(R2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST-segment Elevation Myocardial Infarction (STEMI)

Clinical Trials on Thrombus aspiration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe