Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
Recruiting now · Not applicable
Conditions studied: Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention
In brief
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).
Key facts
- Study ID
- NCT05554588
- Run by
- China-Japan Friendship Hospital
- People needed
- 2500
- Starts
- 2022-09-13
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2022-09-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- 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
You may not qualify 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
- 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
Where it is running
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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