Bivalirudin foR Acute Myocardial Infarction underGoing Angioplasty in CHinese patienTs. (BRIGHT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
-
Drug: Bivalirudin
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 |
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:
- 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;
- Preoperative 48 hours were used for class, heparin/low molecular heparin, warfarin, etc of anticoagulant drugs or than cutting LuDing patients elimination;
- 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.;
- With larger may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
- Nearly a month have deep puncture and major surgery history (including eye or brain surgery) person;
- Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis;
- Has nothing to do with the treatment of uncontrolled hypertension > 180/110 MMHG
- Routine blood anomaly (hemoglobin < 100 g/L, platelet count < 100 * 109 / L);
- 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);
- severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2) person;
- have heparin in thrombopenia interviewer;
- 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;
- pregnant women, lactation and planning of women patients;
- the researchers think that doesn't fit to participate in this study any situation.
Contacts and Locations| Contact: Liang Zhenyang, Doctor | +862428897309 | liangzhenyang@yahoo.com.cn |
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 May 16, 2013