Reduce Bolus Injection of Bivalirudin

Han Yaling, MD

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: Bivalirudin

Study type: Interventional

Funder types: Other

Identifiers

NCT03588611

RE-20180628

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 4 patient groups

Low dose group with eGFR ≥60ml/min

Experimental group

Description:

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.

Treatment:

Drug: Bivalirudin

Drug: Bivalirudin

Standard dose group with eGFR ≥ 60ml/min

Active Comparator group

Description:

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 .

Treatment:

Drug: Bivalirudin

Drug: Bivalirudin

Standard dose group with eGFR <60ml/min

Active Comparator group

Description:

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 .

Treatment:

Drug: Bivalirudin

Drug: Bivalirudin

Low dose group with eGFR <60ml/min

Experimental group

Description:

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.

Treatment:

Drug: Bivalirudin

Drug: Bivalirudin