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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01696110
First received: August 22, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Drug: Bivalirudin
Drug: heparin
Drug: heparin plus tirofiban
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • Net Adverse Clinical Events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings


Secondary Outcome Measures:
  • Net adverse clinical events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings

  • any bleedings (BARC class) [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    including all BARC class (class 1-5)

  • Major adverse cardiac and cerebral events (MACCE) [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
    a composite of all cause death, reinfarction, target vessel revascularization or stroke


Other Outcome Measures:
  • Thrombocytopenia [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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

  • stent thrombosis [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: Yes ]
    by ARC definition


Enrollment: 2194
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, lasted for at least 30 min; if ACT<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given; after procedure, the maintenance dose of bivalirudin should be decreased to 0.2mg/kg per h infusion
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
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
Drug: heparin
heparin monotherapy
Drug: heparin plus tirofiban
combined use of heparin and tirofiban during PCI
Other Name: brand name of tirofiban: Xinweining

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01696110

  Show 81 Study Locations
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital,China
  More Information

No publications provided

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
Study First Received: August 22, 2012
Last Updated: July 7, 2014
Health Authority: China: Ministry of Health

Keywords provided by 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
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014