Thrombus Aspiration in STEMI Patients With High Thrombus Burden

Not Applicable

Recruiting

• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

• Registration Number: NCT04212494
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-27
• Study Start: 2020-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-08-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3838

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	up to180 days	The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Stroke	up to 30 days	The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular
Composite adverse cardiocerebrovascular events	up to 1 year	The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke.

Trial Locations

Locations (50)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

The Second People's Hospital of Nanhai District; 🇨🇳 Foshan, Guangdong, China

First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University); 🇨🇳 Foshan, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou Panyu Central Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou General Hospital of Guangzhou Military Command; 🇨🇳 Guangzhou, Guangdong, China

The first Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

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