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

STEMI With Multivessel Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475835
• Other study ID #: XJTU1AF2020LSK-017
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yihui Xiao
• Phone: +86-18220824850
• Email: sbw_514[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Disease
• STEMI With Multivessel Coronary Disease

Intervention

Drug:
• Bivalirudin
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.
• Heparin
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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	Major adverse cardiac and cerebral events (MACE)	A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke	30 days
Secondary	Major adverse cardiac and cerebral events (MACE)	A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke	6 months
Secondary	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	30 days
Secondary	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	6 months
Secondary	Stent thrombosis	Stent thrombosis as defined by ARC ARC=Academic Research Consortium	Hospitalization
Secondary	Stent thrombosis	Stent thrombosis as defined by ARC ARC=Academic Research Consortium	30 days
Secondary	Stent thrombosis	Stent thrombosis as defined by ARC ARC=Academic Research Consortium	6 months