Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Acute Coronary Syndrome Clinical Trial

— ATTRACTIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554588
• Other study ID #: CSCF2021B02
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: September 2022
• Source: China-Japan Friendship Hospital
• Contact: Zhen Zhang, Doctor
• Phone: +86 15210849352
• Email: bjmuzz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Intrathrombus Thrombolysis During Primary PCI
Intrathrombus Thrombolysis During Primary PCI
• Aspiration Thrombectomy During Primary PCI
Aspiration Thrombectomy During Primary PCI

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Rate of all-cause mortality	Rate of all-cause mortality	up to 1 year
Other	Percentage of myocardial blush grade(MBG) of 0 or 1	Percentage of MBG 0 or 1	up to 30 days
Other	Percentage of ST-segment resolution above 70%	Percentage of ST-segment resolution above 70%	up to 30 days
Other	Percentage of TIMI flow grade 3	Percentage of TIMI flow grade 3	up to 30 days
Other	Incidence of side branch occlusion	Incidence of side branch occlusion	up to 30 days
Other	Incidence of distal embolism	Incidence of distal embolism	up to 30 days
Other	Rate of target vessel dissection	Rate of target vessel dissection assessed by coronary angiography	up to 30 days
Primary	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	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
Secondary	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
Secondary	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