Status:
UNKNOWN
Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
STEMI With Multivessel Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, open label, cohort study, in which a total of 100 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during short-term intervention ...
Detailed Description
The 2017 guideline gives a class IIA recommendation ('should be considered') for complete revascularisation in patients presenting with STEMI and multivessel disease, which is approximately 50% of the...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Acute STEMI (including patients within 12 h of symptom onset, or 24-48 h with recurrent or ongoing chest pain chest pain, persistent ST-segment elevation or new left bundle branch block.
- Staged intervention of non-infarction related artery within 5 days after PPCI during Hospitalization.
- Signed informed consent.
Exclusion
- Cardiogenic shock.
- Received thrombolytic therapy or used any anticoagulant drugs within 48 hours before randomized.
- Active bleeding, recent bleeding events or bleeding tendency.
- History of surgery in the last 1 month.
- Suspicious symptoms of aortic dissection, pericarditis and endocarditis.
- Blood pressure \> 180/110 mmHg.
- Hemoglobin \< 100 g/L, Platelet count \<100×10(9)/L, Transaminase 3 times upper limit of normality or Creatinine clearance \<30ml/min.
- History of Heparin-Induced Thrombocytopenia.
- Allergic to any research drug or device.
- Pregnancy or lactation.
- Any condition that makes the patient unsuitable for PCI or may interfere with the study.
- Patient disagrees or fails to sign the written informed consent.
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04475835
Start Date
January 12 2021
End Date
December 1 2022
Last Update
May 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061