Comparing two methods for treating blood clots during heart procedures
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
This study is testing two different ways to remove blood clots during heart procedures to see which one helps people with heart attacks do better over the next year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05554588 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled trial investigates the effectiveness of intrathrombus thrombolysis versus manual aspiration thrombectomy in patients with ST-Segment Elevation Myocardial Infarction (STEMI) and high thrombus burden undergoing primary percutaneous coronary intervention (PPCI). Participants will be assigned to one of the two treatment methods to evaluate which approach better reduces major adverse cardiovascular events over a one-year period. The study aims to provide insights into optimal treatment strategies for patients with significant blood clots during heart attacks.
Who should consider this trial
Good fit: Ideal candidates are STEMI patients with high thrombus burden presenting within 12 hours of symptom onset or 12-24 hours with persistent symptoms.
Not a fit: Patients who have undergone previous coronary artery bypass grafting (CABG) or have a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients experiencing severe heart attacks.
How similar studies have performed: Other studies have explored similar interventions, but this specific comparison of intrathrombus thrombolysis and aspiration thrombectomy in high thrombus burden STEMI patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhen Zhang, Doctor
- Email: bjmuzz@163.com
- Phone: +86 15210849352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.