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A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow during Primary PCI for the Acute Myocardial InfartiON,ERUPTION

A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow during Primary PCI for the Acute Myocardial InfartiON,ERUPTION

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17010745
Enrollment
Unknown
Registered
2017-02-27
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

STEMI

Interventions

Recombinant HUman Prourokinase:the Coronary Flow
TIrofiban:the Coronary Flow
normal saline:the Coronary Flow

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Male and female aged 18 to 75 years old; 2) symptoms <12 hours, with thrombolytic indications, excluding thrombolytic contraindications ST-segment elevation myocardial infarction patients; 3) willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1) patients who have undergone intravenous thrombolysis in patients with PCI; 2) history of intracranial hemorrhage; 3) ischemic stroke within 3 months; 4) Suspected aortic dissection; 5) active bleeding or bleeding factors (including menstruation); 6) severe head and face damage within 3 months; 7) Severe or not well controlled hypertension (SBP> 180mmHg or DBP> 110mmHg); 8) 3 weeks of severe trauma or major surgery or can not oppress the bleeding; 9) patients with malignant tumors; 10) combined with severe liver and kidney dysfunction; 11) pregnant women, lactating women or women who may be pregnant; 12) known to study drug or contrast agent allergies or contraindications; 13) patients after coronary artery bypass grafting; 14) coronary angiography showed criminal blood flow TIMI3 grade, and no obvious signs of thrombosis; Patients also participate in other clinical studies.

Design outcomes

Primary

MeasureTime frame
cTFC Myocardial perfusion after PCI;

Secondary

MeasureTime frame
MBG Myocardial perfusion after PCI;Postoperative 2 hours ECG ST segment fall range;CTnT and CK-MB peaks;LVEF and serum NT-proBNP levels were measured at 1 day and 30 days after operation;Thirty - day postoperative myocardial infarction was used to assess infarct size;30 days postoperative major cardiovascular events (MACE) (including death, reinfarction, target vessel revascularization);

Countries

China

Contacts

Public ContactDong Huang

Zhongshan Hospital Affiliated to Fudan University

huang.dong@zs-hospital.sh.cn+86 13512142875

Outcome results

None listed

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