Clinical trial NCT04212494: Thrombus Aspiration in STEMI Patients With High Thrombus Burden
Official title: Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: Thrombus Aspiration
Coronary Intervention
Thrombus Burden
ST-segment Elevation Myocardial Infarction
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhongshan People's Hospital, Guangdong, China
name: Kaiping Central Hospital
name: Second Affiliated Hospital of Shantou University Medical College
name: The Third Xiangya Hospital of Central South University
name: Sihui City People's Hospital
name: Shenzhen Baoan District Shiyan People's Hospital
name: People's Hospital of Nanxiong County
name: Yuebei People's Hospital
name: Weifang Medical University
name: Wuzhou Gongren Hospital
name: Dafeng Hospital of Chaoyang District in Shantou City
name: Shenzhen Baoan People's Hospital
name: Dongguan People's Hospital
name: Yangchun People's Hospital
name: Taishan People's Hospital
name: The Second People's Hospital of Foshan
name: Guangzhou Hospital of integrated Traditional and West Medicine
name: Guangning People's Hospital
name: Foshan Sanshui District People's Hospital
name: Qingyuan People's Hospital
name: Luhe County People's Hospital
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: The Fourth People's Hospital of Chenzhou
name: People's Hospital of Dapu County
name: Shenzhen People's Hospital
name: Heyuan people's Hospital
name: Huaiji People's Hospital
name: People's Hospital of Yingde City
name: Qingyuan Hospital of Traditional Chinese Medicine Affiliated To Guangzhou University of Traditional Chinese Medicine
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: The Third Affiliated Hospital of Guangzhou Medical University
name: Lianzhou People's Hospital
name: Lianping Xian Ren Ming Yi Yuan
name: Guangxi Zhuang Autonomous Region Nationalities Hospital
name: Liuzhou Municipal Liutie Central Hospital
name: Chen Zhou 3RD People's Hospital
name: Longgang District People's Hospital of Shenzhen
name: The Affiliated Shunde Hospital of Jinan University
name: Shenzhen Longhua District Central Hospital
name: Shantou Central Hospital
name: Tongxiang First People's Hospital
name: Bobai County People's Hospital, Guangxi
name: Meizhou Traditional Chinese Medicine Hospital
name: The Third Affiliated Hospital of Sun Yat-Sen University, Yuedong Hospital
name: Shenzhen Third People's Hospital
name: Yangjiang People's Hospital
name: Jiangmen Central Hospital
name: Eighth Affiliated Hospital, Sun Yat-sen University
name: The First People's Hospital of Kashgar Erea
name: First People's Hospital of Foshan
name: Zhaoqing Gaoyao People's Hospital
name: People's Hospital of Nanhai District, Foshan
name: The Second Affiliated Hospital of Dalian Medical University
name: Nanning Second People's Hospital
name: The Second People's Hospital of Nanhai District of Foshan
name: Shangyou People's Hospital
First posted: 2019-12-27
Enrollment: 3838
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: up to180 days
Secondary outcomes:
measure: Stroke
timeFrame: up to 30 days
measure: Composite adverse cardiocerebrovascular events
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Foshan
country: China
facility: First People's Hospital of Foshan
state: Guangdong
city: Foshan
country: China
facility: The Second People's Hospital of Nanhai District
state: Guangdong
city: Foshan
country: China
facility: First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou General Hospital of Guangzhou Military Command
state: Guangdong
city: Guangzhou
country: China
facility: The first Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Third People's Hospital
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Kaiping
country: China
facility: Kaiping Central Hospital
state: Guangdong
city: Maoming
country: China
facility: Maoming People's Hospital
state: Guangdong
city: Nanxiong
country: China
facility: Nanxiong people's Hospital
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou university Medical College
state: Guangdong
city: Shaoguan
country: China
facility: Yue Bei People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Eighth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Bao'an District People's Hospital
state: Guangdong
city: Taishan
country: China
facility: Taishan people's Hospital
state: Guangdong
city: Yangjiang
country: China
facility: People's Hospital of Yangjiang City
state: Guangdong
city: Zhanjiang
country: China
facility: The Second Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Zhaoqing
country: China
facility: Sihui people's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai people's Hospital
state: Guangdong
city: Guilin
country: China
facility: Guilin people's Hospital
state: Guangxi
city: Haikou
country: China
facility: The Second Clinical College of Hainan Medical University
state: Hainan
city: Haikou
country: China
facility: Hainan People's Hospital
state: Hainan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Ganzhou
country: China
facility: GanZhou Municopal Hospital
state: Jiangxi
city: Ganzhou
country: China
facility: Shangyou Hospital
state: Jiangxi
city: Weifang
country: China
facility: Affiliated Hospital, Weifang Medical University
state: Shandong
city: Xi'an
country: China
facility: The first Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Kashgar
country: China
facility: Kashgar first people's Hospital
state: Xinjiang
city: Urumqi
country: China
facility: The First Affilicated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yan'an Hospital of Kunming City
state: Yunnan
city: Shaoxing
country: China
facility: Shaoxing people's Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
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