Bivalirudin in Acute Myocardial Infarction

Phase 3

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Bivalirudin; Drug: heparin

• Registration Number: NCT02897037
• Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-09
• Study First Posted: 2016-09-12
• Status Verified: 2016-11
• Study Start: 2016-11
• Last Update Submitted: 2016-11-25
• Last Update Posted: 2016-11-28
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 380

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bivalirudin	Bivalirudin	Bivalirudin will be started in the cath lab, 0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; if ACT\<225s 5min after bolus, an additional dose of 0.3mg/kg bolus should be given. After procedure, a prolonged infusion (1.75mg/kg per h) will be given for at least 30 min (totally no more than 4 h) followed by a reduced dose infusion (0.2mg/kg per h) up to 20 h.
Heparin monotherapy	heparin	100 IU/kg intravenous bolus. If ACT \<225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Events	30 days	A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

Secondary Outcome Measures

Name	Time	Method
Any bleedings (BARC class)	30 days	Including all BARC class (class 3-5)
Major adverse cardiac events (MACE)	30 days	A composite of all cause death, reinfarction, target vessel revascularization or stroke

Trial Locations

Locations (1)

Department of Cardiology，General Hospital of Shenyang Military Region; 🇨🇳 Shanyang, Liaoning, China