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Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI

Primary Purpose

STEMI With Multivessel Coronary Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bivalirudin
Heparin
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI With Multivessel Coronary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Heparin

Arm Description

Bivalirudin with prolonged full dose infusion during PCI

Heparin 100U/kg

Outcomes

Primary Outcome Measures

Net adverse clinical events (NACE)
A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5). BARC=Bleeding Academic Research Consortium

Secondary Outcome Measures

Major adverse cardiac and cerebral events (MACE)
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Major adverse cardiac and cerebral events (MACE)
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Bleeding
Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred. BARC=Bleeding Academic Research Consortium
Bleeding
Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred. BARC=Bleeding Academic Research Consortium
Stent thrombosis
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Stent thrombosis
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Stent thrombosis
Stent thrombosis as defined by ARC ARC=Academic Research Consortium

Full Information

First Posted
July 15, 2020
Last Updated
April 26, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04475835
Brief Title
Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI
Official Title
Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention. NACE, MACE, any type of BARC bleeding, stent thrombosis will be evaluated in 30 days and 6 months after recruitment.
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 STEMI population. Staged multivessel PCI during hospitalization (3-5 days after PPCI) is common in contemporary practice. Patients undergoing primary PCI should receive enhanced antithrombotic therapy, includes DAPT and and parenteral anticoagulant, which caused an increased bleeding risk. In addition, repeated use of heparin in a short time may increase the incidence of HIT. Direct thrombin inhibitor bivalirudin, demonstrated a reduced risk of bleeding and an overall favorable profile including reduced NACE. This is a randomized, open label, cohort study, which is aimed to investigate the safety and efficacy of bivalirudin during short-term intervention of non-infarction related artery for acute ST-segment elevation myocardial infarction after emergency percutaneous coronary intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI With Multivessel Coronary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
Bivalirudin with prolonged full dose infusion during PCI
Arm Title
Heparin
Arm Type
Active Comparator
Arm Description
Heparin 100U/kg
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of heparin should be administered by need.
Primary Outcome Measure Information:
Title
Net adverse clinical events (NACE)
Description
A composite of major adverse cardiac or cerebral events (all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke) or any bleeding as defined by BARC definition (grades 1-5). BARC=Bleeding Academic Research Consortium
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Major adverse cardiac and cerebral events (MACE)
Description
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Time Frame
30 days
Title
Major adverse cardiac and cerebral events (MACE)
Description
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
Time Frame
6 months
Title
Bleeding
Description
Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred. BARC=Bleeding Academic Research Consortium
Time Frame
30 days
Title
Bleeding
Description
Bleeding as defined by BARC definition (grades 1-5). Bleeding was considered medically actionable if BARC types 2-5 and was considered major if BARC types 3-5 occurred. BARC=Bleeding Academic Research Consortium
Time Frame
6 months
Title
Stent thrombosis
Description
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Time Frame
Hospitalization
Title
Stent thrombosis
Description
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Time Frame
30 days
Title
Stent thrombosis
Description
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yihui Xiao
Phone
+86-18220824850
Email
sbw_514@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yihui Xiao
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yihui Xiao
Phone
+86-18220824850
Email
sbw_514@163.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery After PPCI of STEMI

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