Reduce Bolus Injection of Bivalirudin

The Noninferiority and Safety of Bivalirudin Between REDUCEd and Standard BOLUSin Percutaneous Coronary Intervention Patients Stratified by Renal Function

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03588611

Enrollment

204

Registered

2018-07-17

Start date

2019-10-01

Completion date

2021-06-26

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

bivalirudin, bolus injection, activated clotting time, Renal insufficiency

Brief summary

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.

Interventions

DRUGBivalirudin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The area under the curve of the ACT values for both groups	During operation	We will record the ACT values of 0 min, 5 min, 10 min, and 30 min after bolus injection of bivalirudin in patients undergoing PCI,and the area of the closed pattern under the curve will be calculated, and the anticoagulant effect of bivalirudin will be evaluated by the area under the ACT line.

Secondary

Measure	Time frame	Description
Incidence of bleeding and ischaemic events during hospitalization after surgery .	In hospital	Bleeding events are defined as BARC grade 1-5. Ischemic events are defined as stroke, nonfatal myocardial reinfarction, ischemic-driven target vessel revascularization.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026