NCT01696110|CompletedPhase 4DMC

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

BRIGHT

Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial

Shenyang Northern Hospital ClinicalTrials.gov

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2 other identifiers

SYNH201200012011BAI11B07

Study Type

interventional

Target

2,194

Locations

1 country

Sites

Timeline

RegisteredSep 2012

StartedAug 2012

CompletionJul 2014

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,194

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Aug 2012

Geographic Reach

1 country

81 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

Study Start

First participant enrolled

August 1, 2012

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed

1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed

Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

August 22, 2012

Last Update Submit

September 30, 2014

Conditions

Acute Myocardial Infarction Percutaneous Coronary Intervention

Keywords

BivalirudinAcute myocardial infarctionpercutaneous transluminal coronary angioplasty

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Net adverse clinical events
1 year
any bleedings (BARC class)
30 day
Major adverse cardiac and cerebral events (MACCE)
30 days and 1 year

Other Outcomes (2)

Thrombocytopenia
30 days
stent thrombosis
30 days and 1 year

Study Arms (3)

Bivalirudin

EXPERIMENTAL

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.

Drug: Bivalirudin

Heparin monotherapy

ACTIVE COMPARATOR

100 IU/kg intravenous bolus. If ACT \<225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.

Drug: heparin

heparin plus tirofiban

ACTIVE COMPARATOR

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

Drug: heparinDrug: heparin plus tirofiban

Interventions

BivalirudinDRUG

Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.

Also known as: Taijianing

Bivalirudin

heparinDRUG

heparin monotherapy

Heparin monotherapyheparin plus tirofiban

heparin plus tirofibanDRUG

combined use of heparin and tirofiban during PCI

Also known as: brand name of tirofiban: Xinweining

heparin plus tirofiban

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 to 80 years old
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
Avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure.
Provide written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shenyang Northern Hospitallead

Study Sites (81)

1 st Hosp. of Anhui Med Univ.

Hefei, Anhui, 230000, China

Location

Anhui Provincial Hosp.

Hefei, Anhui, 230000, China

Location

3rd Hosp. of Beijing Univ.