Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

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

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.

Study Overview

• Status: Unknown
• Conditions: Aging; Acute Coronary Syndrome; Percutaneous Coronary Intervention; Anticoagulants and Bleeding Disorders
• Intervention / Treatment: Drug: Bivalirudin; Drug: Heparin

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shaoke Meng, M.D.; Phone Number: +86 18098875772; Email: shaokemeng@dmu.edu.cn
• Study Contact Backup: Name: Rongchong Huang, Ph.D.; Phone Number: +86 18841182000; Email: rchuang@aliyun.com

Study Locations

• China
  • Dalian, China, 116011
    • Recruiting
    • The First Affiliated Hospital of Dalian Medical University
    • Contact: Yinan Wang; Phone Number: 3015 +86-411-83635963

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Heparin	Drug: 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.
EXPERIMENTAL: Bivalirudin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Major bleeding	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Stent thrombosis ,TVR ,TLR	Rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation.	30 days
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
Stent thrombosis ,TVR ,TLR	rate of stent thrombosis,unplanned target-vessel revascularization and target lesion revascularisation	180 days
Major bleeding	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.	30 days
Major bleeding	BARC types 3-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding.	180days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University
• Collaborators: Beijing Friendship Hospital
• Investigators: Principal Investigator: Shaoke Meng, M.D., The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 8, 2019
• Primary Completion (ANTICIPATED): July 30, 2020
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (ACTUAL): August 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Percutaneous Coronary Intervention; Acute Coronary Syndrome; Bivalirudin
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Hematologic Diseases; Hemorrhagic Disorders; Syndrome; Hemostatic Disorders; Blood Coagulation Disorders; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin
• Other Study ID Numbers: PJ-KS-KY-2019-38(X)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No