Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI (ATTRACTIVE)

A Randomized Trial of Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients With High Thrombus Burden

This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(PPCI).

Study Overview

• Status: Recruiting
• Conditions: ST Elevation Myocardial Infarction; Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Intervention / Treatment: Procedure: Intrathrombus Thrombolysis During Primary PCI; Procedure: Aspiration Thrombectomy During Primary PCI

Detailed Description

The hypothesis for ATTRACTIVE trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(MACEs), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in STEMI patients with HTB undergoing PPCI.

• Study Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen Zhang, Doctor; Phone Number: +86 15210849352; Email: bjmuzz@163.com
• Study Contact Backup: Name: Zhaoxue Sheng, Doctor; Phone Number: +86 15600268925; Email: shengzhaoxue@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Zhen Zhang; Phone Number: +8615210849352; Email: bjmuzz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients presenting with:

   • Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
   • Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
2. Referred for PPCI
3. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia

4. High thrombus burden:

   • TIMI thrombus grade 3 or 4 after emergency coronary angiography
   • Or TIMI thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows TIMI thrombus grade 5
5. Informed consent

Exclusion Criteria:

1. Rescue PCI after systemic thrombolysis
2. Previous CABG history
3. Life expectancy<1 year
4. Active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding
5. Serious hepatic or kidney dysfunction
6. Pregnancy and lactation
7. Uncontrolled hypertension (>180/100mmHg)
8. Previous hemorrhagic stroke or ischemic stroke in past 3 months
9. Cardiogenic shock or cardio-pulmonary resuscitation
10. Informed consent cannot be obtained or follow-up cannot be completed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrathrombus thrombolysis; Intrathrombus thrombolysis with microcatheter or pierced bolloon during PPCI	Procedure: Intrathrombus Thrombolysis During Primary PCI; Intrathrombus Thrombolysis During Primary PCI
Active Comparator: Aspiration thrombectomy; Aspiration thrombectomy during PPCI	Procedure: Aspiration Thrombectomy During Primary PCI; Aspiration Thrombectomy During Primary PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of major adverse cardiovascular events (MACEs)	Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization	up to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ischemic stroke and transient ischemic attack (TIA)	Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days	up to 30 days
Rate of major bleeding evens (BARC type 2, 3 and 5)	Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days	up to 30 days
Rate of key net benefit outcome	cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis, target-vessel revascularization, stroke and major bleeding evens (BARC 2,3 and 5)	up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of primary outcome at 30 days and 1 year	Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization at 30 days and 1 year	up to 1 year
Rate of individual components of primary outcome	Rate of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization assessed separately at 30 days, 180 days and 1 year	up to 1 year
Rate of all-cause mortality	Rate of all-cause mortality	up to 1 year
Percentage of myocardial blush grade(MBG) of 0 or 1	Percentage of MBG 0 or 1	up to 30 days
Percentage of ST-segment resolution above 70%	Percentage of ST-segment resolution above 70%	up to 30 days
Percentage of TIMI flow grade 3	Percentage of TIMI flow grade 3	up to 30 days
Incidence of side branch occlusion	Incidence of side branch occlusion	up to 30 days
Incidence of distal embolism	Incidence of distal embolism	up to 30 days
Rate of target vessel dissection	Rate of target vessel dissection assessed by coronary angiography	up to 30 days

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Study Chair: Jingang Zheng, Doctor, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): September 1, 2026

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: CSCF2021B02

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