Trial | NCT02897037  Report issue

Title

Bivalirudin in Acute Myocardial Infarction
Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    380
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 Started
Nov 30
2016
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Nov 28
2016
Estimate

Drug Bivalirudin

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

  • Other names: Taijianing

Drug heparin

heparin monotherapy

  • Other names: Gansu

Bivalirudin Experimental

Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.

Heparin monotherapy Active Comparator

100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.

Criteria 

Inclusion Criteria:

Age 18 to 80 years old
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)
Provide written informed consent.

Exclusion Criteria:

Age <18 or >80 years.
Any anticoagulant drugs were regularly used within 3 months.
Any anticoagulant agents were used 48 h before randomization.
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.
Hemoglobin < 90 g/L or platelet count < 100 * 109 / L.
Untreated or uncontrolled hypertension > 180/110 mmHg.
Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
Heparin induced thrombocytopenia.
Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
Pregnancy , lactation or plan to be pregnant.
Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time < 6 months.
Unsuitable for PCI.
Attended any clinical trial 1 month before randomised.
No Results Posted