NCT05554588 Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
| NCT ID | NCT05554588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2022-09-13 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2022-09-13 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Jingang Zheng, Doctor
STUDY CHAIR
China-Japan Friendship Hospital
Frequently Asked Questions
Who can join the NCT05554588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05554588 currently recruiting?
Yes, NCT05554588 is actively recruiting participants. Contact the research team at bjmuzz@163.com for enrollment information.
Where is the NCT05554588 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05554588 clinical trial?
NCT05554588 is sponsored by China-Japan Friendship Hospital. The principal investigator is Jingang Zheng, Doctor at China-Japan Friendship Hospital. The trial plans to enroll 2,500 participants.