search
Back to results

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

Primary Purpose

STEMI, Percutaneous Coronary Intervention, Aged

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bivalirudin
Heparin
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI focused on measuring Major adverse cardiac events (MACEs), bivalirudin

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bivalirudin

Heparin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Major adverse cardiac events
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Major bleeding
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding

Secondary Outcome Measures

Major adverse cardiac events
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Stent thrombosis ,TVR ,TLR
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Major adverse cardiac events
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Stent thrombosis ,TVR ,TLR
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation

Full Information

First Posted
March 18, 2019
Last Updated
March 19, 2019
Sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Beijing Friendship Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03882775
Brief Title
Bivalirudin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction
Acronym
BEST
Official Title
Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
July 14, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
Collaborators
Beijing Friendship Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Percutaneous Coronary Intervention, Aged
Keywords
Major adverse cardiac events (MACEs), bivalirudin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
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.
Arm Title
Heparin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Intervention Description
Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
heparin with or without gpi during emergency PCI.
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Time Frame
7 days
Title
Major bleeding
Description
BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Major adverse cardiac events
Description
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Time Frame
30 days
Title
Stent thrombosis ,TVR ,TLR
Description
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Time Frame
30 days
Title
Major adverse cardiac events
Description
a composite of cardiac death, reinfarction, heart failure,ischemic stroke,frequent post infarction angina，Ventricular tachycardia or fibrillation requiring electrical cardioversion or defibrillation.
Time Frame
180 days
Title
Stent thrombosis ,TVR ,TLR
Description
rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongchong Huang, M.D.
Phone
+86 411 83635963
Ext
7127
Email
rchuang@dlmedu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchong Huang, M.D.
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Huang, M.D.
Phone
+86-411-83635963
Ext
3035
Email
dyyykjb@126.com
First Name & Middle Initial & Last Name & Degree
Yinan Wang, M.S.
Phone
+86-411-83635963
Ext
3015

12. IPD Sharing Statement

Citations:
PubMed Identifier
23636477
Citation
De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI; European Society of Cardiology Working Group on Thrombosis Task Force on Anticoagulants in Heart Disease. Parenteral anticoagulants in heart disease: current status and perspectives (Section II). Position paper of the ESC Working Group on Thrombosis-Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 May;109(5):769-86. doi: 10.1160/TH12-06-0403. Epub 2013 Mar 28.
Results Reference
background
PubMed Identifier
11451763
Citation
Hirsh J, Anand SS, Halperin JL, Fuster V; American Heart Association. AHA Scientific Statement: Guide to anticoagulant therapy: heparin: a statement for healthcare professionals from the American Heart Association. Arterioscler Thromb Vasc Biol. 2001 Jul;21(7):E9-9. doi: 10.1161/hq0701.093520. No abstract available.
Results Reference
background
PubMed Identifier
12087346
Citation
Robson R, White H, Aylward P, Frampton C. Bivalirudin pharmacokinetics and pharmacodynamics: effect of renal function, dose, and gender. Clin Pharmacol Ther. 2002 Jun;71(6):433-9. doi: 10.1067/mcp.2002.124522.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs