search
Back to results

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

Primary Purpose

Acute Myocardial Infarction, Percutaneous Coronary Intervention

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Bivalirudin
heparin
heparin plus tirofiban
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 1 st Hosp. of Anhui Med Univ.
  • Anhui Provincial Hosp.
  • 3rd Hosp. of Beijing Univ.
  • Beijing Anzhen Hosp.
  • Beijing CAPF General Hosp.
  • Beijing Chaoyang Hosp.
  • Beijing Friendship Hosp.
  • Beijing General Hosp. of PLA
  • Beijing Hosp.
  • Beijing Luhe Hosp.
  • General Hosp of PLA (1)
  • General Hosp. of PLA(2)
  • Navy General Hosp. of PLA
  • No.304 Hosp. of PLA
  • No.306 Hosp. of PLA
  • Peking Univ. First Hosp.
  • The 2nd artillery general Hosp. of PLA
  • Chongqing Daping Hosp.
  • Fujian Med Univ. Uion Hosp.
  • 1 st Hosp. of Lanzhou Univ.
  • Lanzhou General Hosp. of PLA
  • 1 st Hosp. of Guangzhou MU
  • 1st Hosp. of Zhongshan MU
  • Guangdong General Hosp.
  • Guangzhou General Hosp. of PLA
  • 1 st Hosp. of Guangxi Med Univ.
  • No.252 Hosp. of PLA
  • Cangzhou Centeral Hosp.
  • Qinhuangdao No.1 Hosp.
  • Hebei General Hosp.
  • Shijiazhuang Peace Hosp.
  • Tangshan Gongren Hosp.
  • Daqing General Hosp. of OF.
  • No.152 Hosp.
  • Wuhan Asican Heart Hosp.
  • Wuhan General Hosp of PLA
  • Nanjing First Hosp.
  • Xuzhou Med Col. Affiliated Hosp.
  • Xuzhou No.4 Hosp.
  • 2 nd Hosp. of Nanchang Univ.
  • 1st Hosp of Jilin Univ.
  • 2nd Hosp of Jilin Univ.
  • 3rd Hosp of Jilin Univ.
  • Meihekou Central Hosp.
  • Dalian Zhongshan Hosp.
  • No.210 Hosp of PLA
  • No.313 Hosp. of PLA
  • 1st Hosp. of Liaoning MC
  • 3 rd Hosp. of Liaoning Med Col.
  • No.463 Hosp of PLA
  • Shenzhou Hosp. of SMC
  • Yingkou Centeral Hosp.
  • General Hosp. of Ningxia MU
  • Ji'nan General Hosp. of PLA
  • Affiliated Hosp. of Jining MC
  • Taian Central Hosp.
  • Yantaishan Hosp.
  • No. 148 Hosp.
  • Huashan Hosp.
  • Shanghai jingan people's hosp.
  • Shanghai Renji Hosp.
  • 1st Hosp. of Shanxi Med Univ.
  • Shanxi Cardiovascular Hosp.
  • Taiyuan Central Hosp.
  • 2 nd Hosp. of Xi'an Med Col.
  • Shanxi General Hosp. of CAPF
  • Shanxi General Hosp.
  • Tangdu Hosp.
  • Xijing Hosp.
  • Yanan Univ. affiliated Hosp.
  • Yuncheng Central Hosp.
  • Chengdu General Hosp. of PLA
  • Chengdu No.2 Hosp.
  • No.254 Hosp. of PLA
  • Tianjin CAPF Hosp.
  • Tianjin Chest Hosp.
  • Tianjin No.3 Hosp.
  • Tianjin People's Hosp.
  • Kunming General Hosp. of PLA
  • 2nd Hosp. of Zhejiang Univ.
  • Zhejiang Hosp.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Bivalirudin

Heparin monotherapy

heparin plus tirofiban

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2012
Last Updated
September 30, 2014
Sponsor
Shenyang Northern Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01696110
Brief Title
BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial.
Acronym
BRIGHT
Official Title
Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Percutaneous Coronary Intervention
Keywords
Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bivalirudin
Arm Type
Experimental
Arm Description
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.
Arm Title
Heparin monotherapy
Arm Type
Active Comparator
Arm Description
100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
Arm Title
heparin plus tirofiban
Arm Type
Active Comparator
Arm Description
heparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Taijianing
Intervention Description
Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
Intervention Type
Drug
Intervention Name(s)
heparin
Intervention Description
heparin monotherapy
Intervention Type
Drug
Intervention Name(s)
heparin plus tirofiban
Other Intervention Name(s)
brand name of tirofiban: Xinweining
Intervention Description
combined use of heparin and tirofiban during PCI
Primary Outcome Measure Information:
Title
Net Adverse Clinical Events
Description
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Net adverse clinical events
Description
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
Time Frame
1 year
Title
any bleedings (BARC class)
Description
including all BARC class (class 1-5)
Time Frame
30 day
Title
Major adverse cardiac and cerebral events (MACCE)
Description
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Time Frame
30 days and 1 year
Other Pre-specified Outcome Measures:
Title
Thrombocytopenia
Description
Defined as a decrease of platelet count of more than 50% or more than 150000 platelet/mm3 compared with baseline within 24h after study drug administration
Time Frame
30 days
Title
stent thrombosis
Description
by ARC definition
Time Frame
30 days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD
Organizational Affiliation
Shenyang Northern Hospital,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
1 st Hosp. of Anhui Med Univ.
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Anhui Provincial Hosp.
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
3rd Hosp. of Beijing Univ.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Anzhen Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing CAPF General Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Chaoyang Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Friendship Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing General Hosp. of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Luhe Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
General Hosp of PLA (1)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
General Hosp. of PLA(2)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Navy General Hosp. of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
No.304 Hosp. of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
No.306 Hosp. of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking Univ. First Hosp.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The 2nd artillery general Hosp. of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Chongqing Daping Hosp.
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Name
Fujian Med Univ. Uion Hosp.
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
1 st Hosp. of Lanzhou Univ.
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
Lanzhou General Hosp. of PLA
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Facility Name
1 st Hosp. of Guangzhou MU
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
1st Hosp. of Zhongshan MU
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong General Hosp.
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangzhou General Hosp. of PLA
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
1 st Hosp. of Guangxi Med Univ.
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
210000
Country
China
Facility Name
No.252 Hosp. of PLA
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Cangzhou Centeral Hosp.
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061000
Country
China
Facility Name
Qinhuangdao No.1 Hosp.
City
Qinhuangdao
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Hebei General Hosp.
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Shijiazhuang Peace Hosp.
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Tangshan Gongren Hosp.
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
Daqing General Hosp. of OF.
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
No.152 Hosp.
City
Pingdingshan
State/Province
Henan
ZIP/Postal Code
467000
Country
China
Facility Name
Wuhan Asican Heart Hosp.
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Wuhan General Hosp of PLA
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Nanjing First Hosp.
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Xuzhou Med Col. Affiliated Hosp.
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Xuzhou No.4 Hosp.
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
2 nd Hosp. of Nanchang Univ.
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
1st Hosp of Jilin Univ.
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
2nd Hosp of Jilin Univ.
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
3rd Hosp of Jilin Univ.
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Meihekou Central Hosp.
City
Meihekou
State/Province
Jilin
ZIP/Postal Code
135000
Country
China
Facility Name
Dalian Zhongshan Hosp.
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Facility Name
No.210 Hosp of PLA
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Facility Name
No.313 Hosp. of PLA
City
Huludao
State/Province
Liaoning
ZIP/Postal Code
125000
Country
China
Facility Name
1st Hosp. of Liaoning MC
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Facility Name
3 rd Hosp. of Liaoning Med Col.
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China
Facility Name
No.463 Hosp of PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Shenzhou Hosp. of SMC
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Yingkou Centeral Hosp.
City
Yingkou
State/Province
Liaoning
ZIP/Postal Code
115000
Country
China
Facility Name
General Hosp. of Ningxia MU
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750000
Country
China
Facility Name
Ji'nan General Hosp. of PLA
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
Affiliated Hosp. of Jining MC
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Facility Name
Taian Central Hosp.
City
Taian
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Facility Name
Yantaishan Hosp.
City
Yantai
State/Province
Shandong
ZIP/Postal Code
261400
Country
China
Facility Name
No. 148 Hosp.
City
Zibo
State/Province
Shandong
ZIP/Postal Code
255000
Country
China
Facility Name
Huashan Hosp.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai jingan people's hosp.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Renji Hosp.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
1st Hosp. of Shanxi Med Univ.
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Shanxi Cardiovascular Hosp.
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Taiyuan Central Hosp.
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
2 nd Hosp. of Xi'an Med Col.
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Shanxi General Hosp. of CAPF
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Shanxi General Hosp.
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Tangdu Hosp.
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Xijing Hosp.
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Yanan Univ. affiliated Hosp.
City
Yanan
State/Province
Shanxi
ZIP/Postal Code
716000
Country
China
Facility Name
Yuncheng Central Hosp.
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044000
Country
China
Facility Name
Chengdu General Hosp. of PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
Chengdu No.2 Hosp.
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
No.254 Hosp. of PLA
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin CAPF Hosp.
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin Chest Hosp.
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin No.3 Hosp.
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin People's Hosp.
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Kunming General Hosp. of PLA
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Facility Name
2nd Hosp. of Zhejiang Univ.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Zhejiang Hosp.
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26762481
Citation
Liang Z, Li Y, Wang J, Wang D, Wang S, Ma L, Liu H, Yang L, Stone GW, Han Y. The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial. Catheter Cardiovasc Interv. 2016 Mar;87 Suppl 1:608-15. doi: 10.1002/ccd.26407. Epub 2016 Jan 13.
Results Reference
derived
PubMed Identifier
25775052
Citation
Han Y, Guo J, Zheng Y, Zang H, Su X, Wang Y, Chen S, Jiang T, Yang P, Chen J, Jiang D, Jing Q, Liang Z, Liu H, Zhao X, Li J, Li Y, Xu B, Stone GW; BRIGHT Investigators. Bivalirudin vs heparin with or without tirofiban during primary percutaneous coronary intervention in acute myocardial infarction: the BRIGHT randomized clinical trial. JAMA. 2015 Apr 7;313(13):1336-46. doi: 10.1001/jama.2015.2323.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs