Reduce Bolus Injection of Bivalirudin

NCT03588611 | Completed Phase 4

• 1 other identifier: RE-20180628
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

bivalirudin; bolus injection; activated clotting time; Renal insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of bleeding and ischaemic events during hospitalization after surgery .

  In hospital

Study Arms (4)

Low dose group with eGFR ≥60ml/min

EXPERIMENTAL

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.

Drug: Bivalirudin

Standard dose group with eGFR ≥ 60ml/min

ACTIVE COMPARATOR

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 .

Drug: Bivalirudin

Standard dose group with eGFR <60ml/min

ACTIVE COMPARATOR

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 .

Drug: Bivalirudin

Low dose group with eGFR <60ml/min

EXPERIMENTAL

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.

Drug: Bivalirudin

Interventions

Bivalirudin DRUG

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

Standard dose group with eGFR <60ml/min; Standard dose group with eGFR ≥ 60ml/min

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Han Yaling, MD: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Location

Related Publications (1)

• Hu Q, Han YL, Zhou TN, Wang XZ, Zhang QY. Efficacy and Safety of the Reduced Bivalirudin in Patients Undergoing Coronary Angiography or Percutaneous Coronary Intervention Stratified by Renal Function (REDUCE BOLUS): A Single-Blind, Stratified Randomized, Non-inferiority Trial. Front Cardiovasc Med. 2022 Apr 25;9:864048. doi: 10.3389/fcvm.2022.864048. eCollection 2022.

  PMID: 35548446 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Renal Insufficiency

Interventions

bivalirudin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The noninferiority and safety of bivalirudin between REDUCEd and standard BOLUSin percutaneous coronary intervention patients stratified by renal function

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 17, 2018
• Study Start: October 1, 2019
• Primary Completion: June 26, 2021
• Study Completion: June 26, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

CN (1)