Reduce Bolus Injection of Bivalirudin

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-06-26

Brief Summary

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There are fewer studies on the bleeding risk of the currently administered bivalirudin bolus injection dose and the safety of bivalirudin in patients with CKD. A non-inferiority, randomized, stratified controlled trial study has been conducted to evaluate the non-inferiority and safety of the low dose (80%) bolus injections of bivalirudin in patients with or without CKD.This study will provide a safe, effective and economical anticoagulation strategy.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low dose group with eGFR ≥60ml/min

This arm, we will choose the patients who's eGFR ≥60ml/min and reduce the bivalirudin bolus injection dose to 80% of the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery to reduce the ACT value caused by the bolus injection.

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Standard dose group with eGFR ≥ 60ml/min

This arm, we will choose the patients who's eGFR ≥60ml/min and use the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery .

Group Type ACTIVE_COMPARATOR

Bivalirudin

Intervention Type DRUG

0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Standard dose group with eGFR <60ml/min

This arm, we will choose the patients who's eGFR \<60ml/min and use the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery .

Group Type ACTIVE_COMPARATOR

Bivalirudin

Intervention Type DRUG

0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Low dose group with eGFR <60ml/min

This arm, we will choose the patients who's eGFR \<60ml/min and reduce the bivalirudin bolus injection dose to 80% of the standard dose in clinical practice, and we will adjuste the bivalirudin maintenance dose and rate according to the ACT time during surgery to reduce the ACT value caused by the bolus injection.

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Interventions

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Bivalirudin

0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Intervention Type DRUG

Bivalirudin

0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1 Age 18 to 80 years old; 2 Medically judge to require coronary angiography; 3 Patients agree to use bivalirudin 4 Patients signe informed consent.

Exclusion Criteria

* 1.Cardiogenic shock; 2.Thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; 3.Active or recent major bleeding or bleeding predisposition; 4.Major surgery within 1 month; 5.Clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; blood pressure higher than 180/110 mm Hg; 6.Known hemoglobin less than 10 g/dL,platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal; 7.History of heparin-induced thrombocytopenia; 8.Ellergy to any of the study drugs or devices; 9.Eregnancy or lactation; 10.Any condition making PCI unsuitable or that might interfere with study adherence; 11.Patient unwilling or unable to provide written informed consent 12. Researchers think it is not suitable to participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Han Yaling, MD

The noninferiority and safety of bivalirudin between REDUCEd and standard BOLUSin percutaneous coronary intervention patients stratified by renal function

Responsibility Role SPONSOR_INVESTIGATOR