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

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

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.

Study Overview

• Status: Recruiting
• Conditions: STEMI With Multivessel Coronary Disease
• Intervention / Treatment: Drug: Bivalirudin; Drug: Heparin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihui Xiao; Phone Number: +86-18220824850; Email: sbw_514@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Yihui Xiao; Phone Number: +86-18220824850; Email: sbw_514@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bivalirudin; Bivalirudin with prolonged full dose infusion during PCI	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.
Active Comparator: Heparin; Heparin 100U/kg	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yihui Xiao, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin
• Other Study ID Numbers: XJTU1AF2020LSK-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No