Current partner codePEPTIDESDE
NCT03588611·Phase 4·INTERVENTIONAL

Reduce Bolus Injection of Bivalirudin

Status

Completed

Phase

Phase 4

Enrollment

204

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Bivalirudin

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

DRUG

Bivalirudin

0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;

Timeline

From registration to results.

  1. First posted

    Jul 17, 2018

  2. Study start

    Oct 1, 2019

  3. Primary completion

    Jun 26, 2021

  4. Study completion

    Jun 26, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Aug 9, 2021

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

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