Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Coronary Disease Clinical Trial

Official title:

Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02787317
• Other study ID #: ChinaPLA general hospital
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 24, 2016
• Last updated: May 31, 2016
• Start date: May 2016
• Est. completion date: November 2018

Study information

• Verified date: May 2016
• Source: Chinese PLA General Hospital
• Contact: Yundai chen, doctor
• Phone: +08613581886786
• Email: dingyutinkle[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1770
• Est. completion date: November 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• bivalirudin
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
• Heparin
Heparin is used in patients undergoing percutaneous coronary intervention.

Locations

Country	Name	City	State
China	ChinaPLAGH	Beijing	Beijing
China	ChinaPLAGH	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 Ca — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creatine kinase-MB increase	creatine kinase-MB increase >3 times upper limit of normal	up to postprocedural 72 hours	Yes
Secondary	bleeding(BARC class)	including BARC class 2-5	30 days and 1 year	Yes
Secondary	major adverse cardiac or cerebral events	a composite of all cause death, reinfarction, target vessel revascularization or stroke	30 days and 1 year	No
Secondary	Net Adverse Clinical Events	a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding	30 days and 1 year	No