Clinical trial NCT05554588: Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Percutaneous Coronary Intervention
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of major adverse cardiovascular events (MACEs)
timeFrame: up to 180 days
Secondary outcomes:
measure: Rate of ischemic stroke and transient ischemic attack (TIA)
timeFrame: up to 30 days
measure: Rate of major bleeding evens (BARC type 2, 3 and 5)
timeFrame: up to 30 days
measure: Rate of key net benefit outcome
timeFrame: up to 1 year
Other outcomes:
measure: Rate of primary outcome at 30 days and 1 year
timeFrame: up to 1 year
measure: Rate of individual components of primary outcome
timeFrame: up to 1 year
measure: Rate of all-cause mortality
timeFrame: up to 1 year
measure: Percentage of myocardial blush grade(MBG) of 0 or 1
timeFrame: up to 30 days
measure: Percentage of ST-segment resolution above 70%
timeFrame: up to 30 days
measure: Percentage of TIMI flow grade 3
timeFrame: up to 30 days
measure: Incidence of side branch occlusion
timeFrame: up to 30 days
measure: Incidence of distal embolism
timeFrame: up to 30 days
measure: Rate of target vessel dissection
timeFrame: up to 30 days
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jingang Zheng, Doctor
role: STUDY_CHAIR
References: