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A Randomized, Parallel-Controlled, Multi-Center Study of the Effects of Intracoronary Recombinant Human Prourokinase or Thrombus Aspiration on Coronary Flow During Primary PCI and Mid-Term Outcomes for ST Elevation Myocardial Infartion

A Randomized, Parallel-Controlled, Multi-Center Study of the Effects of Intracoronary Recombinant Human Prourokinase or Thrombus Aspiration on Coronary Flow During Primary PCI and Mid-Term Outcomes for ST Elevation Myocardial Infartion

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042906
Enrollment
Unknown
Registered
2021-01-31
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infartion

Interventions

Intracoronary thrombolysis group:20mg of recombinant human urokinase was injected into the proximal end of intracoronal thrombus
thrombus aspiration group:routine method of thrombus aspiration

Sponsors

The Fourth Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged from 18 to 75 years (including 18 and 75 years old) are not limited in gender; 2. Patients with symptoms less than 12 hours, indications for thrombolysis and exclusion of contraindications for thrombolysis; 3. Patients who can understand and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with suspected aortic dissection; 2. Patients with history of intracranial hemorrhage; 3. Patients with ischemic stroke within 3 months; 4. Severe head and face injury within 3 months; 5. Patients with active bleeding or bleeding factors (including menstruation); 6. Patients with severe trauma or major operation or vascular bleeding that cannot be compressed within 3 weeks; 7. Patients with severe or uncontrolled hypertension (SBP > 180mmhg or DBP > 110mmhg); 8. Patients who have undergone rescue PCI with intravenous thrombolysis; 9. Pregnant women, lactating women or women who are likely to be pregnant; 10. Patients who are known to be allergic to the study drug or contrast agent or have contraindications; 11. Patients after CABG; 12. Patients with severe hepatic and renal insufficiency; 13. Patients with malignant tumor; 14. Patients taking anticoagulants for a long time (such as warfarin, rivaroxaban, etc.); 15. Patients whose coronary angiography showed TIMI grade 3 of culprit vessel flow without obvious thrombus sign; 16. Patients who participated in other clinical studies at the same time; 17. The researcher thinks that it is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Cardiovascular death within 180 days;recurrent AMI within 180 days;cardiogenic shock within 180 days;New or aggravated NYHA IV heart failure within 180 days;

Secondary

MeasureTime frame
(TIMI Myocardial Blush Grades, MBG) after PCI;TIMI Myocardial Perfusion Grade, TMPG after PCI;TIMI flow grades;Corrected TIMI Frame Count, cTFC;The ST segment resolution after PCI;

Countries

China

Contacts

Public ContactWei Yang

The Fourth Affiliated Hospital of Harbin Medical University

hydyangwei@tom.com+86 13845099775

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026