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

Percutaneous Coronary Intervention Clinical Trial

— BEST  

Official title:

Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882775
• Other study ID #: PJ-KY-2018-117
• Status: Recruiting
• Phase: Phase 4
• Start date: January 16, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Rongchong Huang, M.D.
• Phone: +86 411 83635963
• Email: rchuang[@]dlmedu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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 = ?)

• 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

Related Conditions & MeSH terms

• Aged
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• STEMI

Intervention

Drug:
• Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
• Heparin
heparin with or without gpi during emergency PCI.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University	Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Primary	Major bleeding	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding	7 days
Secondary	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.	30 days
Secondary	Stent thrombosis ,TVR ,TLR	rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation	30 days
Secondary	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.	180 days
Secondary	Stent thrombosis ,TVR ,TLR	rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation	180 days