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: September 30, 2014
Last verified: September 2014

August 22, 2012
September 30, 2014
August 2012
July 2013   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01696110 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
  • 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
Not Provided
 
BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.
Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Myocardial Infarction
  • Percutaneous Coronary Intervention
  • Drug: Bivalirudin
    Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
    Other Name: Taijianing
  • Drug: heparin
    heparin monotherapy
  • Drug: heparin plus tirofiban
    combined use of heparin and tirofiban during PCI
    Other Name: brand name of tirofiban: Xinweining
  • 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.
    Intervention: Drug: Bivalirudin
  • 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.
    Intervention: Drug: heparin
  • 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.
    Interventions:
    • Drug: heparin
    • Drug: heparin plus tirofiban
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2194
July 2014
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01696110
SYNH20120001, 2011BAI11B07
Yes
Han Yaling, Shenyang Northern Hospital
Shenyang Northern Hospital
Not Provided
Principal Investigator: Yaling Han, MD Shenyang Northern Hospital,China
Shenyang Northern Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP