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BivaliRudin in Acute Myocardi...

BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Last Updated: 2014-10-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

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The study would enrolled a total of 2100 AMI patients undergoing PCI to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor.

All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

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Detailed Description

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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 2100 AMI patients undergoing percutaneous coronary intervention (PCI) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. All enrolled patients would be followed-up to 30 days, 6 months, and 1 year. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Conditions

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Acute Myocardial Infarction Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

heparin

Intervention Type DRUG

heparin monotherapy

heparin plus tirofiban

heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.

Group Type ACTIVE_COMPARATOR

heparin

Intervention Type DRUG

heparin monotherapy

heparin plus tirofiban

Intervention Type DRUG

combined use of heparin and tirofiban during PCI

Interventions

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Bivalirudin

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

Intervention Type DRUG

heparin

heparin monotherapy

Intervention Type DRUG

heparin plus tirofiban

combined use of heparin and tirofiban during PCI

Intervention Type DRUG

Other Intervention Names

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Taijianing brand name of tirofiban: Xinweining

Eligibility Criteria

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Inclusion Criteria

1. Age 18 to 80 years old
2. Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI
3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
4. Provide written informed consent.

Exclusion Criteria

1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock.
2. Any anticoagulant agents were used 48 h before randomization.
3. 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.;
4. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
5. Deep puncture or major surgery (including eye or brain surgery) within 1 month.
6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
7. Untreated or uncontrolled hypertension \> 180/110 mmHg.
8. Hemoglobin \< 100 g/L or platelet count \< 100 \* 109 / L.
9. Elevated AST, ALT level higher than three times of the normal upper limit.
10. severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2).
11. Heparin induced thrombocytopenia.
12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
13. Pregnancy or lactation.
14. Researchers think that doesn't fit to participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Han Yaling

director of the department of cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaling Han, MD

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital,China

Locations

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1 st Hosp. of Anhui Med Univ.

Hefei, Anhui, China

Site Status