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NCT Number: NCT05554588

Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Zhen Zhang

CONTACT

[email protected]

+8615210849352

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Referred for PPCI
  • Within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia
  • 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
  • Informed consent

Exclusion criteria

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

Treatment and study plan

Intrathrombus Thrombolysis During Primary PCI

Procedure

Intrathrombus Thrombolysis During Primary PCI

Aspiration Thrombectomy During Primary PCI

Procedure

Aspiration Thrombectomy During Primary PCI

Primary outcomes

  1. Rate of major adverse cardiovascular events (MACEs)

    Time frame: 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 outcomes

  1. Rate of ischemic stroke and transient ischemic attack (TIA)

    Time frame: 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)

    Time frame: 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

    Time frame: 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 outcomes

  1. Rate of primary outcome at 30 days and 1 year

    Time frame: 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

    Time frame: 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

    Time frame: up to 1 year

    Rate of all-cause mortality

  4. Percentage of myocardial blush grade(MBG) of 0 or 1

    Time frame: up to 30 days

    Percentage of MBG 0 or 1

  5. Percentage of ST-segment resolution above 70%

    Time frame: up to 30 days

    Percentage of ST-segment resolution above 70%

  6. Percentage of TIMI flow grade 3

    Time frame: up to 30 days

    Percentage of TIMI flow grade 3

  7. Incidence of side branch occlusion

    Time frame: up to 30 days

    Incidence of side branch occlusion

  8. Incidence of distal embolism

    Time frame: up to 30 days

    Incidence of distal embolism

  9. Rate of target vessel dissection

    Time frame: up to 30 days

    Rate of target vessel dissection assessed by coronary angiography

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaoxue Sheng, Doctor

CONTACT

[email protected]

+86 15600268925

Zhen Zhang, Doctor

CONTACT

[email protected]

+86 15210849352

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study 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

Acronym: ATTRACTIVE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2022
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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