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

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ClinicalTrials.gov Identifier: NCT01696110
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Percutaneous Coronary Intervention Drug: Bivalirudin Drug: heparin Drug: heparin plus tirofiban Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial
Study Start Date : August 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Other Name: Taijianing

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

Active Comparator: 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.
Drug: heparin
heparin monotherapy

Drug: heparin plus tirofiban
combined use of heparin and tirofiban during PCI
Other Name: brand name of tirofiban: Xinweining




Primary Outcome Measures :
  1. Net Adverse Clinical Events [ Time Frame: 30 days ]
    A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings


Secondary Outcome Measures :
  1. Net adverse clinical events [ Time Frame: 1 year ]
    a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings

  2. any bleedings (BARC class) [ Time Frame: 30 day ]
    including all BARC class (class 1-5)

  3. Major adverse cardiac and cerebral events (MACCE) [ Time Frame: 30 days and 1 year ]
    a composite of all cause death, reinfarction, target vessel revascularization or stroke


Other Outcome Measures:
  1. Thrombocytopenia [ Time Frame: 30 days ]
    Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration

  2. stent thrombosis [ Time Frame: 30 days and 1 year ]
    by ARC definition



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696110


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Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital,China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Han Yaling, director of the department of cardiology, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT01696110     History of Changes
Other Study ID Numbers: SYNH20120001
2011BAI11B07 ( Other Grant/Funding Number: China National Science and Technology support project plan )
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Keywords provided by Han Yaling, Shenyang Northern Hospital:
Bivalirudin
Acute myocardial infarction
percutaneous transluminal coronary angioplasty

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Calcium heparin
Bivalirudin
Heparin
Hirudins
Tirofiban
Krestin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Antithrombins