BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.

Phase 4

Completed

• Conditions: Percutaneous Coronary Intervention; Acute Myocardial Infarction
• Interventions: Drug: heparin; Drug: Bivalirudin; Drug: heparin plus tirofiban

• Registration Number: NCT01696110
• Lead Sponsor: Shenyang Northern Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-28
• Primary Completion: 2013-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2194

Inclusion Criteria

1. Age 18 to 80 years old
2. Planned emergency PCI for acute myocardial infarction (STEMI or NSTEMI) Symptom onset within 12h for STEMI (or within 24 h for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB) Symptom onset within 72h for NSTEMI
3. Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
4. Provide written informed consent.

Exclusion Criteria

1. Unsuitable for PCI; treatment by thrombolysis within 72 hours of acute ST-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock.
2. Any anticoagulant agents were used 48 h before randomization.
3. 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.;
4. Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.),
5. Deep puncture or major surgery (including eye or brain surgery) within 1 month.
6. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
7. Untreated or uncontrolled hypertension > 180/110 mmHg.
8. Hemoglobin < 100 g/L or platelet count < 100 * 109 / L.
9. Elevated AST, ALT level higher than three times of the normal upper limit.
10. severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
11. Heparin induced thrombocytopenia.
12. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
13. Pregnancy or lactation.
14. Researchers think that doesn't fit to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
heparin plus tirofiban	heparin	heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
heparin plus tirofiban	heparin plus tirofiban	heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
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.

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
Major adverse cardiac and cerebral events (MACCE)	30 days and 1 year	a composite of all cause death, reinfarction, target vessel revascularization or stroke
any bleedings (BARC class)	30 day	including all BARC class (class 1-5)
Net adverse clinical events	1 year	a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings

Trial Locations

Locations (81)

1 st Hosp. of Anhui Med Univ.; 🇨🇳 Hefei, Anhui, China

Anhui Provincial Hosp.; 🇨🇳 Hefei, Anhui, China

3rd Hosp. of Beijing Univ.; 🇨🇳 Beijing, Beijing, China

Beijing Anzhen Hosp.; 🇨🇳 Beijing, Beijing, China

Beijing CAPF General Hosp.; 🇨🇳 Beijing, Beijing, China

Beijing Chaoyang Hosp.; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hosp.; 🇨🇳 Beijing, Beijing, China

Beijing General Hosp. of PLA; 🇨🇳 Beijing, Beijing, China

Beijing Hosp.; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hosp.; 🇨🇳 Beijing, Beijing, China

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