Current partner codePEPTIDESDE
NCT02787317·Phase 4·INTERVENTIONAL

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Status

Unknown

Phase

Phase 4

Enrollment

1,770

Locations

2

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Full detailed description

Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.

Interventions

Treatment arms and agents.

DRUG

bivalirudin

Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.

DRUG

Heparin

Heparin is used in patients undergoing percutaneous coronary intervention.

Timeline

From registration to results.

  1. First posted

    Jun 1, 2016

  2. Study start

    May 2016

  3. Primary completion

    Oct 2017

  4. Study completion

    Nov 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jun 1, 2016

Outcomes

What the study measures.

Primary outcomes

creatine kinase-MB increase

Time frame · up to postprocedural 72 hours

creatine kinase-MB increase \>3 times upper limit of normal

Secondary outcomes

bleeding(BARC class)

Time frame · 30 days and 1 year

including BARC class 2-5

major adverse cardiac or cerebral events

Time frame · 30 days and 1 year

a composite of all cause death, reinfarction, target vessel revascularization or stroke

Net Adverse Clinical Events

Time frame · 30 days and 1 year

a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding

Eligibility

Who can take part.

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

Inclusion Criteria: * Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required. Exclusion Criteria: * cardiogenic shock; * thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization; * active or recent major bleeding or bleeding predisposition; * major surgery within 1 month; * clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis; * blood pressure higher than 180/110 mm Hg; * known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min; * history of heparin-induced thrombocytopenia; * allergy to any of the study drugs or devices; * pregnancy or lactation; * any condition making PCI unsuitable or that might interfere with study adherence; and * patient unwilling or unable to provide written informed consent.

Study locations

2 registered sites.

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

ChinaPLAGH

Beijing, Beijing Municipality, China

ChinaPLAGH

Beijing, Beijing Municipality, China

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.