Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02897037
Other study ID # Bright2
Secondary ID
Status Recruiting
Phase Phase 3
First received September 7, 2016
Last updated November 25, 2016
Start date November 2016
Est. completion date December 2017

Study information

Verified date November 2016
Source Shenzhen Salubris Pharmaceuticals Co., Ltd.
Contact Jiangjing Long, Dr.
Phone 86-10-58696282
Email longjianjing@salubris.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Drug:
Bivalirudin
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
heparin
heparin monotherapy

Locations

Country Name City State
China Department of Cardiology,General Hospital of Shenyang Military Region Shanyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Shenzhen Salubris Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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
See also
  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