Clinical trial NCT04046029: Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.
Official title: Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Aging
Anticoagulants and Bleeding Disorders
Keywords: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Elderly
Bivalirudin
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
First posted: 2019-08-06
Enrollment: 240
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 coronary syndrome undergoing elective percutaneous coronary intervention.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 7 days
measure: Major bleeding
timeFrame: 7 days
Secondary outcomes:
measure: Major adverse cardiac events
timeFrame: 30 days
measure: Stent thrombosis ,TVR ,TLR
timeFrame: 30 days
measure: Major adverse cardiac events
timeFrame: 180 days
measure: Stent thrombosis ,TVR ,TLR
timeFrame: 180 days
measure: Major bleeding
timeFrame: 30 days
measure: Major bleeding
timeFrame: 180days
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Shaoke Meng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.