Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
380 participants
INTERVENTIONAL
2016-11-30
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bivalirudin
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.
Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Heparin monotherapy
100 IU/kg intravenous bolus. If ACT \<225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
heparin
heparin monotherapy
Interventions
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Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
heparin
heparin monotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
Yes
Sponsors
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Shenzhen Salubris Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Department of Cardiology，General Hospital of Shenyang Military Region
Shanyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Zhenyang Liang, Dr.
Role: primary
Yi Li
Role: backup
Other Identifiers
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Bright2
Identifier Type: -
Identifier Source: org_study_id