Bivalirudin foR Acute Myocardial Infarction underGoing Angioplasty in CHinese patienTs. (BRIGHT)

Expanded access is currently available for this treatment.
Verified April 2013 by Shenyang Northern Hospital
Sponsor:
Collaborators:
The First Hospital of Nanjing Medical University
Shanghai Jing'an District People's Hospital
Fu Wai Hospital, Beijing, China
Sino-Japanese Friendship Hospital of Jilin University
Wuhan Asia Heart Hospital
Daqing Oil Field Hospital
Liuzhou People's Hospital
Affiliated Hospital of Zunyi Medical College
Guangzhou General Hospital of Guangzhou Military Command
Second Hospital of Jilin University
First Hospital of Jilin University
Lanzhou General Hospital
The First Affiliated Hospital of Guangzhou Medical University
The Second Affiliated Hospital of Kunming Medical University
Nanchang Second Hospital
Cangzhou Central Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Affiliated Hospital of Xuzhou Medical College
Xuzhou Central Hospital
Bethune International Peace Hospital
Tianjin Medical University General Hospital
Tianjin Chest Hospital
The First Affiliated Hospital of Zhengzhou University
Shanxi Institute of Cardiovascular Diseases
Henan Provincial Hospital
Liaoning Medical University
Shenyang Shen Zhou Hospital
Yingkou Central Hospital
Jilin Meihekoushi Central Hospital
Ningxia Medical University
Anhui Provincial Hospital
Peking Union Medical College Hospital
Harbin Medical University
Beijing Friendship Hospital
General Hospital of Beijing PLA Military Region
LanZhou University
Guangdong General Hospital
First Affiliated Hospital, Sun Yat-Sen University
Xijing Hospital
Peking University Third Hospital
Beijing Anzhen Hospital
Beijing Chao Yang Hospital
Peking University People's Hospital
Second Hospital of Hebei Medical University
Guangxi Medical University
Peking University First Hospital
Shanxi Yuncheng Central Hospital
Hebei Provincial People's Hospital
Beijing Hospital
Kunming General Hospital
Beijing Luhe Hospital
Jining Medical University
West China Hospital
Chengdu PLA General Hospital
Ningxia Hui Autonomous Region Hospital
Anhui Medical University
RenJi Hospital
Huashan Hospital
Nankai University
Tianjin TEDA Hospital
Information provided by (Responsible Party):
Han Yaling, Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT01696110
First received: August 22, 2012
Last updated: April 8, 2013
Last verified: April 2013

August 22, 2012
April 8, 2013
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01696110 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bivalirudin foR Acute Myocardial Infarction underGoing Angioplasty in CHinese patienTs.
Bivalirudin for Acute Myocardial Infarction Undergoing Angioplasty in Chinese Patients: a Randomized, Single-blind, 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.

Expanded Access
Not Provided
Not Provided
Acute Myocardial Infarction
Drug: Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Other Name: Taijianing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Available
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • Age 18 to 80 years old
  • Male or female
  • Plan to underwent emergency PCI in patients with acute myocardial infarction (including: type st-elevation myocardial infarction and the non st-elevation myocardial infarction), STEMI onset 12 hours or less (or the 12 to 24 hours still have chest pain or discomfort and continuous st elevation or new happening LBBB patients, NSTEMI within 72 hours for the complete PCI;
  • Try to avoid 30 days to the myocardial infarction criminals vascular other target lesion revascularization completed (if for non-medical reasons plan for other target lesion reascularization, need to be related to the registration perioperative antithrombotic drug and PCI process, and the perioperative antithrombotic drugs must be consistent to the previous PCI, such as heparin, or heparin plus tirofiban ,or bivalirudin).
  • Before PCI specification antiplatelet drugs agreed to participate in the clinical test and preoperative sign written informed consent.

Exclusion Criteria:

  • Have the following situations one of shall be excluded, not in the CARDS:

    1. anticipation (clinical manifestations or coronary CT examination such as tip) or by coronary arteriography (CAG) judgment is not GeHang PCI person; Treatment by thrombolysis within 72 hours of acute st-elevation type myocardial infarction, left main coronary artery disease, cardiogenic shock patients;
    2. Preoperative 48 hours were used for class, heparin/low molecular heparin, warfarin, etc of anticoagulant drugs or than cutting LuDing patients elimination;
    3. Active bleeding or bleeding constitution, bleeding tendency person, including the recent retina or vitreous hemorrhage (1 months), digestive tract and urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) and cerebral infarction history (3 months), etc.;
    4. With larger may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
    5. Nearly a month have deep puncture and major surgery history (including eye or brain surgery) person;
    6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis;
    7. Has nothing to do with the treatment of uncontrolled hypertension > 180/110 MMHG
    8. Routine blood anomaly (hemoglobin < 100 g/L, platelet count < 100 * 109 / L);
    9. liver function index (AST, ALT) a higher than normal amount of the upper limit value of the three times (by myocardial infarction of liver function index increase except);
    10. severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2) person;
    11. have heparin in thrombopenia interviewer;
    12. known to the research of the drugs and instruments allergy (common heparin, bivalirudin aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution;
    13. pregnant women, lactation and planning of women patients;
    14. the researchers think that doesn't fit to participate in this study any situation.
Both
18 Years to 80 Years
Not Provided
Contact: Liang Zhenyang, Doctor +862428897309 liangzhenyang@yahoo.com.cn
Not Provided
 
NCT01696110
SYNH20120001, 2011BAI11B07
Not Provided
Han Yaling, Shenyang Northern Hospital
Shenyang Northern Hospital
  • The First Hospital of Nanjing Medical University
  • Shanghai Jing'an District People's Hospital
  • Fu Wai Hospital, Beijing, China
  • Sino-Japanese Friendship Hospital of Jilin University
  • Wuhan Asia Heart Hospital
  • Daqing Oil Field Hospital
  • Liuzhou People's Hospital
  • Affiliated Hospital of Zunyi Medical College
  • Guangzhou General Hospital of Guangzhou Military Command
  • Second Hospital of Jilin University
  • First Hospital of Jilin University
  • Lanzhou General Hospital
  • The First Affiliated Hospital of Guangzhou Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • Nanchang Second Hospital
  • Cangzhou Central Hospital
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Affiliated Hospital of Xuzhou Medical College
  • Xuzhou Central Hospital
  • Bethune International Peace Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Chest Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Shanxi Institute of Cardiovascular Diseases
  • Henan Provincial Hospital
  • Liaoning Medical University
  • Shenyang Shen Zhou Hospital
  • Yingkou Central Hospital
  • Jilin Meihekoushi Central Hospital
  • Ningxia Medical University
  • Anhui Provincial Hospital
  • Peking Union Medical College Hospital
  • Harbin Medical University
  • Beijing Friendship Hospital
  • General Hospital of Beijing PLA Military Region
  • LanZhou University
  • Guangdong General Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
  • Xijing Hospital
  • Peking University Third Hospital
  • Beijing Anzhen Hospital
  • Beijing Chao Yang Hospital
  • Peking University People's Hospital
  • Second Hospital of Hebei Medical University
  • Guangxi Medical University
  • Peking University First Hospital
  • Shanxi Yuncheng Central Hospital
  • Hebei Provincial People's Hospital
  • Beijing Hospital
  • Kunming General Hospital
  • Beijing Luhe Hospital
  • Jining Medical University
  • West China Hospital
  • Chengdu PLA General Hospital
  • Ningxia Hui Autonomous Region Hospital
  • Anhui Medical University
  • RenJi Hospital
  • Huashan Hospital
  • Nankai University
  • Tianjin TEDA Hospital
Not Provided
Shenyang Northern Hospital
April 2013

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