DRUG
Bivalirudin
0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
Status
Completed
Phase
Phase 4
Enrollment
204
Locations
1
Results
Not posted
Publications
1
Study 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
DRUG
0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
DRUG
0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
Timeline
First posted
Jul 17, 2018
Study start
Oct 1, 2019
Primary completion
Jun 26, 2021
Study completion
Jun 26, 2021
Results posted
Not reported
Registry updated
Aug 9, 2021
Outcomes
The area under the curve of the ACT values for both groups
Time frame · 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.
Incidence of bleeding and ischaemic events during hospitalization after surgery .
Time frame · 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.
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Related trials
Duke University · Coronavirus Infection (COVID-19) · Pulmonary Arterial Hypertension
Not applicable
Recruiting
5,000
2026-07
Sydney Local Health District · Extracorporeal Membrane Oxygenation Complication
Phase 2
Recruiting
80
2026-05
Xiaotong Hou · Extracorporeal Membrane Oxygenation Complication
Not applicable
Recruiting
154
2026-04
Shenyang Northern Hospital · Percutaneous Coronary Intervention · High Bleeding Risk
Phase 4
Not yet recruiting
5,270
2026-02
Stanford University · Heart Failure · Cardiogenic Shock
Phase 2
Recruiting
50
2026-01
NYU Langone Health · Coronary Microvascular Disease · Ischemic Heart Disease
Not applicable
Active, not recruiting
206
2025-11
Shenyang Northern Hospital · ST Elevation Myocardial Infarction
Not applicable
Completed
6,016
2025-08
Peking University First Hospital · Coronary Microvascular Dysfunction
Phase 4
Recruiting
70
2025-08
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.