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

April 26, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Net adverse clinical events (NACE)
Time Frame: 30 days

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebral events (MACE)
Time Frame: 30 days
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
30 days
Major adverse cardiac and cerebral events (MACE)
Time Frame: 6 months
A composite of all-cause death, reinfarction, ischemia-driven target vessel revascularization, or stroke
6 months
Bleeding
Time Frame: 30 days

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
Time Frame: 6 months

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
Time Frame: Hospitalization
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
Hospitalization
Stent thrombosis
Time Frame: 30 days
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
30 days
Stent thrombosis
Time Frame: 6 months
Stent thrombosis as defined by ARC ARC=Academic Research Consortium
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yihui Xiao, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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