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Bivalirudin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction (BEST)

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: NCT03882775
Recruitment Status : Unknown
Verified March 2019 by The First Affiliated Hospital of Dalian Medical University.
Recruitment status was:  Recruiting
First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Beijing Friendship Hospital
Information provided by (Responsible Party):
The First Affiliated Hospital of Dalian Medical University

Study Description
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Brief Summary:
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute ST-segment elevation myocardial infarction undergoing emergency PCI.

Condition or disease Intervention/treatment Phase
STEMI Percutaneous Coronary Intervention Aged Drug: Bivalirudin Drug: Heparin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : July 14, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bivalirudin
Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.
 Drug: Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
Active Comparator: Heparin
Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.
 Drug: Heparin
heparin with or without gpi during emergency PCI.


Outcome Measures
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Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 7 days ]
    a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

  2. Major bleeding [ Time Frame: 7 days ]
    BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding


Secondary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 30 days ]
    a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

  2. Stent thrombosis ,TVR ,TLR [ Time Frame: 30 days ]
    rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

  3. Major adverse cardiac events [ Time Frame: 180 days ]
    a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.

  4. Stent thrombosis ,TVR ,TLR [ Time Frame: 180 days ]
    rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥75 years old;
  • Planned emergency (Symptom onset within 24h) PCI for acute STEMI patients;
  • Life expectancy ≥ 1 year;
  • Provide written informed consent.

Exclusion Criteria:

  • Contraindications to angiography or PCI;
  • Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
  • Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
  • Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2);
  • Elevated AST, ALT level higher than three times of the normal upper limit;
  • Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ)
  • Complicated with immune system diseases；
  • Abnormal hematopoietic system：platelet count < 100 * 109 / L or > 700 * 109 / L，white blood cell count < 3 * 109/L etc;
  • Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
  • Known intolerance, or contraindication to any antithrombotic medication
  • Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
  • Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
  • Patient's inability to fully cooperate with the study protocol
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): NCT03882775


Contacts
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Contact: Rongchong Huang, M.D. +86 411 83635963 ext 7127 rchuang@dlmedu.edu.cn

Locations
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China, Liaoning
The First Affiliated Hospital of Dalian Medical University Recruiting
Dalian, Liaoning, China, 116011
Contact: Wei Huang, M.D.    +86-411-83635963 ext 3035    dyyykjb@126.com   
Contact: Yinan Wang, M.S.    +86-411-83635963 ext 3015      
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Beijing Friendship Hospital
Investigators
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Principal Investigator: Rongchong Huang, M.D. The First Affiliated Hospital of Dalian Medical University
More Information
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Publications:

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Responsible Party: The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03882775    
Other Study ID Numbers: PJ-KY-2018-117
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The First Affiliated Hospital of Dalian Medical University:
Major adverse cardiac events (MACEs)
bivalirudin
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
Bivalirudin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors