Bivalirudin in Elderly Patients Undergoing Elective Percutaneous Coronary Intervention.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-08

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Percutaneous Coronary Intervention Aging Anticoagulants and Bleeding Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bivalirudin

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No