Bivalirudin in Acute Myocardial Infarction

Shenzhen Salubris Pharmaceuticals Co., Ltd.380 enrolled

Overview

The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES. This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.

This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

380

Conditions

Acute Myocardial Infarction

Interventions

BivalirudinDRUG

Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.

heparinDRUG

heparin monotherapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 to 80 years old 2. Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) 3. Provide written informed consent. Exclusion Criteria: 1. Age \<18 or \>80 years. 2. Any anticoagulant drugs were regularly used within 3 months. 3. Any anticoagulant agents were used 48 h before randomization. 4. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc. 5. Hemoglobin \< 90 g/L or platelet count \< 100 \* 109 / L. 6. Untreated or uncontrolled hypertension \> 180/110 mmHg. 7. Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2). 8. Heparin induced thrombocytopenia. 9. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. 10. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. 11. Pregnancy , lactation or plan to be pregnant. 12. Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time \< 6 months. 13. Unsuitable for PCI. 14. Attended any clinical trial 1 month before randomised.

Locations (1)

Department of Cardiology，General Hospital of Shenyang Military Region

Shanyang, Liaoning, China

RECRUITING

Outcomes

Primary Outcomes

Net Adverse Clinical Events

A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

Time frame: 30 days

Secondary Outcomes

Major adverse cardiac events (MACE)

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

Time frame: 30 days

Any bleedings (BARC class)

Including all BARC class (class 3-5)

Time frame: 30 days

Central Contacts

Jiangjing Long, Dr.

CONTACT

86-10-58696282 longjianjing@salubris.cn

Yan Hou, Dr.

CONTACT

86-10-58696282 houyan@salubris.cn

Data from ClinicalTrials.gov

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