Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Aging Clinical Trial

Official title:

Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046029
• Other study ID #: PJ-KS-KY-2019-38(X)
• Status: Recruiting
• Phase: Phase 4
• Start date: July 8, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2019
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Shaoke Meng, M.D.
• Phone: +86 18098875772
• Email: shaokemeng[@]dmu.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 coronary syndrome undergoing elective percutaneous coronary intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age =75 years old;

• Planned elective PCI for patients with acute coronary syndrome;

• 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

• Acute Coronary Syndrome
• Aging
• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Hemostatic Disorders
• Percutaneous Coronary Intervention
• Syndrome

Intervention

Drug:
• 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.
• 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.

Locations

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

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
Secondary	Major bleeding	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.	30 days
Secondary	Major bleeding	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.	180days