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
  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
Acute Myocardial Infarction
Drug: Bivalirudin

Study Type: Expanded Access     What is Expanded Access?
Official Title: Bivalirudin for Acute Myocardial Infarction Undergoing Angioplasty in Chinese Patients: a Randomized, Single-blind, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Shenyang Northern Hospital:

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696110

Contacts
Contact: Liang Zhenyang, Doctor +862428897309 liangzhenyang@yahoo.com.cn

Sponsors and Collaborators
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
  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: April 8, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
Bivalirudin
Acute myocardio infarction
PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Bivalirudin
Hirudins
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014