Bivalirudin in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02897037
• Other study ID #: Bright2
• 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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

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