Reduce Bolus Injection of Bivalirudin

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03588611
• Other study ID #: RE-20180628
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: June 26, 2021

Study information

• Verified date: August 2021
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: June 26, 2021
• Est. primary completion date: June 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• Bivalirudin
0.75mg/kg+ 1.75 mg/kg?h for the duration of PCI;
• Bivalirudin
0.6mg/kg+ 1.75 mg/kg?h for the duration of PCI;

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Han Yaling, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the curve of the ACT values for both groups	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.	During operation
Secondary	Incidence of bleeding and ischaemic events during hospitalization after surgery .	Bleeding events are defined as BARC grade 1-5. Ischemic events are defined as stroke, nonfatal myocardial reinfarction, ischemic-driven target vessel revascularization.	In hospital