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Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI (BRIGHT-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822975
Recruitment Status : Active, not recruiting
First Posted : January 30, 2019
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital

Study Description
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Brief Summary:
This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: Bivalirudin Drug: unfractionated Heparin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6016 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial
Actual Study Start Date : February 14, 2019
Actual Primary Completion Date : May 7, 2022
Estimated Study Completion Date : May 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bivalirudin
Bivalirudin with prolonged full dose infusion during primary 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 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.
Active Comparator: Heparin
Heparin alone during primary PCI
 Drug: unfractionated Heparin
Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is >225 seconds.


Outcome Measures
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Primary Outcome Measures :
  1. Composite of all-cause death or BARC type 3~5 bleeding [ Time Frame: 30 days ]
    BARC=Bleeding academic research consortium


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]
  2. BARC type 3-5 bleeding [ Time Frame: 30 days ]
    BARC=Bleeding academic research consortium

  3. Major adverse cardiac and cerebral events (MACE) [ Time Frame: 30 days ]
    MACE is defined as a composite of all cause death, recurrent myocardial infarction, stroke or ischemic driven target vessel revascuarlization

  4. Net adverse clinical events (NACE) [ Time Frame: 30 days ]
    NACE is defined as a composite of MACE or BARC type 3-5 bleeding

  5. Composite of all-cause death or BARC type 2-5 bleeding [ Time Frame: 30 days ]
    BARC=Bleeding academic research consortium

  6. BARC type 2-5 bleeding [ Time Frame: 30 days ]
    BARC=Bleeding academic research consortium

  7. Stent thrombosis [ Time Frame: 30 days ]
    Definite or probable stent thrombosis according to Academic Research Consortium

  8. Thrombocytopenia [ Time Frame: 30 days ]
    defined as platelet counts less than 150*10^9/L after treatment

  9. All cause mortality [ Time Frame: 1 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any age;
  • STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h;
  • Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
  • Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);
  • The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion Criteria:

  • Not suitable for emergency primary PCI;
  • STEMI treated by thrombolysis;
  • Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI;
  • Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
  • Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
  • Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822975


Locations
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Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
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Principal Investigator: Yaling Han, MD The General Hospital of Northern Theater Command
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Han Yaling, Director, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT03822975    
Other Study ID Numbers: 2018-031
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Yaling, Shenyang Northern Hospital:
Primary percutaneous coronary intervention
anticoagulant agents
bivalirudin
heparin
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heparin
 Calcium heparin
Bivalirudin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors