NCT07551700Not yet recruiting
Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial
Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial (TRAP-MI)
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function in adults with acute ST-segment elevation myocardial infarction (STEMI) and a high blood clot burden in the heart's arteries. The main questions it aims to answer are: * Does PPCI plus manual thrombus aspiration lower the risk of serious heart problems one year after treatment, compared to PPCI alone? * Can manual thrombus aspiration better protect long-term heart function in people with a high blood clot burden? Researchers will compare two groups of participants-one group getting PPCI plus manual thrombus aspiration and one group getting only PPCI-to see if the aspiration treatment leads to fewer serious heart problems, better long-term heart function, and similar safety (including no higher risk of stroke). Participants will: * Have a heart artery scan (coronary angiography) to confirm a high blood clot burden * Be randomly assigned to one of the two treatment groups for their PPCI procedure * Complete follow-up checks at 30 days, 6 months, and 1 year after treatment, including heart function tests (like echocardiograms) * Have heart magnetic resonance (CMR) scans if selected, to measure heart tissue damage and heart function * Have their heart health status and any adverse events recorded throughout the study
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 6760 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Coronary artery disease
- NCT number
- NCT07551700
What you commit to
- Study type: Interventional
- Planned participants: 6760
- From 1 Apr 2026 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A history of previous coronary artery bypass grafting (CABG).
- Concurrent intervention required for non-culprit vessels.
Other illness
- Expected survival time \< 1 year (e.g., advanced malignant tumor).
Lab values
- Severe bleeding tendency (e.g., INR \> 2.5, platelet count \< 50×10⁹/L).
- Severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²).
Other
- Cardiogenic shock (Killip class IV) or requiring mechanical circulatory support.
Who the study is looking for
- Aged ≥18 years old, diagnosed with acute ST-segment elevation myocardial infarction (STEMI) (chest pain plus ST-segment elevation ≥1mm or new-onset left bundle branch block \[LBBB\]) with symptom onset \< 12 hours.
- Planned to undergo primary percutaneous coronary intervention (PPCI).
- High thrombus burden in the target vessel (TIMI thrombus grade ≥3, or visible floating thrombus) confirmed by coronary angiography.
- Reference diameter of the target vessel ≥2.75mm, with the lesion suitable for the passage of an aspiration catheter.
- Provided written informed consent to participate in the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.