ATTRACTIVE: Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

Sponsor
China-Japan Friendship Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05554588
Collaborator
(none)
2,500
1
2
47.6
52.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intrathrombus Thrombolysis During Primary PCI
  • Procedure: Aspiration Thrombectomy During Primary PCI
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 13, 2022
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of major adverse cardiovascular events (MACEs) [up to 180 days]

    Rate of composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure readmission, stent thrombosis and target-vessel revascularization

Secondary Outcome Measures

  1. Rate of ischemic stroke and transient ischemic attack (TIA) [up to 30 days]

    Rate of ischemic stroke and transient ischemic attack (TIA) at 30 days

  2. Rate of major bleeding evens (BARC type 2, 3 and 5) [up to 30 days]

    Rate of major bleeding evens (BARC type 2, 3 and 5) at 30 days

  3. Rate of key net benefit outcome [up to 1 year]

    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)

Other Outcome Measures

  1. Rate of primary outcome at 30 days and 1 year [up to 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

  2. Rate of individual components of primary outcome [up to 1 year]

    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

  3. Rate of all-cause mortality [up to 1 year]

    Rate of all-cause mortality

  4. Percentage of myocardial blush grade(MBG) of 0 or 1 [up to 30 days]

    Percentage of MBG 0 or 1

  5. Percentage of ST-segment resolution above 70% [up to 30 days]

    Percentage of ST-segment resolution above 70%

  6. Percentage of TIMI flow grade 3 [up to 30 days]

    Percentage of TIMI flow grade 3

  7. Incidence of side branch occlusion [up to 30 days]

    Incidence of side branch occlusion

  8. Incidence of distal embolism [up to 30 days]

    Incidence of distal embolism

  9. Rate of target vessel dissection [up to 30 days]

    Rate of target vessel dissection assessed by coronary angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Referred for PPCI

  2. Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia

  3. 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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China-Japan Friendship Hospital Beijing Beijing China 100029

Sponsors and Collaborators

  • China-Japan Friendship Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jingang Zheng, Director of Cardiology, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT05554588
Other Study ID Numbers:
  • CSCF2021B02
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022