Clinical trial NCT02787317: Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
Official title: Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Disease
Keywords: bivalirudin
myocardial injure
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 1770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: creatine kinase-MB increase
timeFrame: up to postprocedural 72 hours
Secondary outcomes:
measure: bleeding（BARC class）
timeFrame: 30 days and 1 year
measure: major adverse cardiac or cerebral events
timeFrame: 30 days and 1 year
measure: Net Adverse Clinical Events
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: ChinaPLAGH
state: Beijing
city: Beijing
country: China
facility: ChinaPLAGH
state: Beijing
Study officials:
References:
citation: Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323.
citation: Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.