Acute Myocardial Infarction Clinical Trial
Official title:
Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial
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 380 AMI patients undergoing percutaneous
coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or
unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | December 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 to 80 years old 2. Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) 3. Provide written informed consent. Exclusion Criteria: 1. Age <18 or >80 years. 2. Any anticoagulant drugs were regularly used within 3 months. 3. Any anticoagulant agents were used 48 h before randomization. 4. 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. 5. Hemoglobin < 90 g/L or platelet count < 100 * 109 / L. 6. Untreated or uncontrolled hypertension > 180/110 mmHg. 7. Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2). 8. Heparin induced thrombocytopenia. 9. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. 10. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. 11. Pregnancy , lactation or plan to be pregnant. 12. Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time < 6 months. 13. Unsuitable for PCI. 14. Attended any clinical trial 1 month before randomised. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Cardiology,General Hospital of Shenyang Military Region | Shanyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Salubris Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Net Adverse Clinical Events | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings | 30 days | No |
Secondary | Major adverse cardiac events (MACE) | A composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days | No |
Secondary | Any bleedings (BARC class) | Including all BARC class (class 3-5) | 30 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04451967 -
Acute Myocardial Infarction Study in Northeastern China
|
||
Completed |
NCT05974397 -
Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
|
||
Not yet recruiting |
NCT04072081 -
Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions
|
N/A | |
Recruiting |
NCT03940443 -
Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
|
||
Recruiting |
NCT03707626 -
Collateral Circulation to LAD and Wellens Sign
|
||
Completed |
NCT02669810 -
EXCELLENT (EXpanded CELL ENdocardiac Transplantation)
|
Phase 2 | |
Not yet recruiting |
NCT04104048 -
Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
|
||
Active, not recruiting |
NCT02915107 -
The SORT OUT IX STEMI OCT Trial
|
N/A | |
Completed |
NCT02896543 -
The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction
|
N/A | |
Completed |
NCT02490969 -
Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19
|
N/A | |
Withdrawn |
NCT01901471 -
Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
|
Phase 2 | |
Completed |
NCT02531165 -
Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
|
N/A | |
Completed |
NCT02312336 -
A Pilot Study of Transcoronary Myocardial Cooling
|
N/A | |
Recruiting |
NCT02071342 -
Study of ABSORB Stent in Acute Myocardial Infarction
|
N/A | |
Terminated |
NCT01972126 -
MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction
|
N/A | |
Completed |
NCT02070913 -
COOL-AMI EU Case Series Clinical Study
|
||
Completed |
NCT01216995 -
Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)
|
Phase 2 | |
Completed |
NCT01887080 -
Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program
|
N/A | |
Withdrawn |
NCT01678339 -
Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
|
N/A | |
Completed |
NCT01627457 -
Heart Cycle Prestudy
|
N/A |