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Compares treatment options for Acute Coronary Syndrome
Official title Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
ClinicalTrials.gov ID: NCT05554588
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.