Thrombus removal during PCI after thrombolysis for STEMI
The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction
This trial will test whether removing clots during PCI improves outcomes for people with STEMI who received thrombolysis and have a high thrombus burden.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06654453 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll about 3,500 patients with ST-segment elevation myocardial infarction who received thrombolytic therapy and were transferred for PCI. Eligible patients must undergo coronary angiography 2–24 hours after thrombolysis and have angiographic TIMI thrombus grade ≥4 with residual stenosis >50%. Participants are randomized to thrombus aspiration plus PCI or to PCI alone, with standard periprocedural care. The primary endpoint is 30-day major adverse cardiovascular events (cardiovascular death, recurrent MI, stroke, or heart failure rehospitalization) with secondary analyses including measures of microcirculation and other clinical outcomes.
Who should consider this trial
Good fit: Adults with STEMI who received thrombolysis, can have angiography within 2–24 hours, show TIMI thrombus grade ≥4 with >50% residual stenosis, have no contraindications to thrombolysis, and can give informed consent are ideal candidates.
Not a fit: Patients in cardiogenic shock, those needing urgent coronary bypass, those with contraindications to thrombolysis, with low thrombus burden, or who cannot meet the 2–24 hour angiography window are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding thrombus aspiration could lower 30-day major cardiac events and improve coronary microcirculation for high-thrombus STEMI patients after thrombolysis.
How similar studies have performed: Previous randomized trials of routine thrombus aspiration during primary PCI showed mixed or neutral results and some safety concerns like increased stroke risk, while targeted use after thrombolysis in high-thrombus patients is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with STEMI. 2. No contraindications for thrombolysis and has received thrombolytic treatment. 3. Undergoing coronary angiography within 2 to 24 hours post-thrombolysis. 4. Angiographic results confirm TIMI thrombus load ≥ 4 and residual stenosis \> 50%. Exclusion Criteria: 1. Contraindications for thrombolysis. 2. Cardiogenic shock. 3. Need for coronary artery bypass grafting. 4. Age less than 18 years. 5. Life expectancy of less than 6 months. 6. Unable to provide informed consent.
Where this trial is running
Changsha, Hunan
- Department of General Surgery, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011 Hunan, PR China — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Shenghua Zhou
- Email: zhoushenghua@csu.edu.cn
- Phone: 073185292012
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.