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Acute Myocardial InfarctionPhase 4BRIGHTNCT01696110

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

A Phase 4 study testing Bivalirudin, heparin and heparin plus tirofiban in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Shenyang Northern Hospital at 81 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Bivalirudin, heparin and heparin plus tirofiban
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,194 participants
Where
81 sitesChina
Study dates
Aug 2012to Jul 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

China81 sites

  • No.252 Hosp. of PLA

    Baoding, Hebei, 071000

  • 3rd Hosp. of Beijing Univ.

    Beijing, Beijing Municipality, 100000

  • Beijing Anzhen Hosp.

    Beijing, Beijing Municipality, 100000

  • Beijing CAPF General Hosp.

    Beijing, Beijing Municipality, 100000

  • Beijing Chaoyang Hosp.

    Beijing, Beijing Municipality, 100000

  • Beijing Friendship Hosp.

    Beijing, Beijing Municipality, 100000

  • Beijing General Hosp. of PLA

    Beijing, Beijing Municipality, 100000

  • Beijing Hosp.

    Beijing, Beijing Municipality, 100000

  • Beijing Luhe Hosp.

    Beijing, Beijing Municipality, 100000

  • General Hosp of PLA (1)

    Beijing, Beijing Municipality, 100000

  • General Hosp. of PLA(2)

    Beijing, Beijing Municipality, 100000

  • Navy General Hosp. of PLA

    Beijing, Beijing Municipality, 100000

  • No.304 Hosp. of PLA

    Beijing, Beijing Municipality, 100000

  • No.306 Hosp. of PLA

    Beijing, Beijing Municipality, 100000

  • Peking Univ. First Hosp.

    Beijing, Beijing Municipality, 100000

  • The 2nd artillery general Hosp. of PLA

    Beijing, Beijing Municipality, 100000

  • Cangzhou Centeral Hosp.

    Cangzhou, Hebei, 061000

  • 1st Hosp of Jilin Univ.

    Changchun, Jilin, 130000

  • 2nd Hosp of Jilin Univ.

    Changchun, Jilin, 130000

  • 3rd Hosp of Jilin Univ.

    Changchun, Jilin, 130000

  • Chengdu General Hosp. of PLA

    Chengdu, Sichuan, 610000

  • Chengdu No.2 Hosp.

    Chengdu, Sichuan, 610000

  • Chongqing Daping Hosp.

    Chongqing, Chongqing Municipality, 400000

  • Dalian Zhongshan Hosp.

    Dalian, Liaoning, 116000

  • No.210 Hosp of PLA

    Dalian, Liaoning, 116000

  • Daqing General Hosp. of OF.

    Daqing, Heilongjiang, 150000

  • Fujian Med Univ. Uion Hosp.

    Fuzhou, Fujian, 350000

  • 1 st Hosp. of Guangzhou MU

    Guangzhou, Guangdong, 510000

  • 1st Hosp. of Zhongshan MU

    Guangzhou, Guangdong, 510000

  • Guangdong General Hosp.

    Guangzhou, Guangdong, 510000

  • Guangzhou General Hosp. of PLA

    Guangzhou, Guangdong, 510000

  • 2nd Hosp. of Zhejiang Univ.

    Hangzhou, Zhejiang, 310000

  • Zhejiang Hosp.

    Hangzhou, Zhejiang, 310000

  • 1 st Hosp. of Anhui Med Univ.

    Hefei, Anhui, 230000

  • Anhui Provincial Hosp.

    Hefei, Anhui, 230000

  • No.313 Hosp. of PLA

    Huludao, Liaoning, 125000

  • Ji'nan General Hosp. of PLA

    Ji'nan, Shandong, 250000

  • Affiliated Hosp. of Jining MC

    Jining, Shandong, 272000

  • 1st Hosp. of Liaoning MC

    Jinzhou, Liaoning, 121000

  • 3 rd Hosp. of Liaoning Med Col.

    Jinzhou, Liaoning, 121000

  • Kunming General Hosp. of PLA

    Kunming, Yunnan, 650000

  • 1 st Hosp. of Lanzhou Univ.

    Lanzhou, Gansu, 730030

  • Lanzhou General Hosp. of PLA

    Lanzhou, Gansu, 730030

  • Meihekou Central Hosp.

    Meihekou, Jilin, 135000

  • 2 nd Hosp. of Nanchang Univ.

    Nanchang, Jiangxi, 330000

  • Nanjing First Hosp.

    Nanjing, Jiangsu, 210000

  • 1 st Hosp. of Guangxi Med Univ.

    Nanning, Guangxi, 210000

  • No.152 Hosp.

    Pingdingshan, Henan, 467000

  • Qinhuangdao No.1 Hosp.

    Qinhuangdao, Hebei, 050000

  • Huashan Hosp.

    Shanghai, Shanghai Municipality, 200000

  • Shanghai jingan people's hosp.

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Renji Hosp.

    Shanghai, Shanghai Municipality, 200000

  • No.463 Hosp of PLA

    Shenyang, Liaoning, 110000

  • Shenzhou Hosp. of SMC

    Shenyang, Liaoning, 110000

  • Hebei General Hosp.

    Shijiazhuang, Hebei, 050000

  • Shijiazhuang Peace Hosp.

    Shijiazhuang, Hebei, 050000

  • Taian Central Hosp.

    Taian, Shandong, 271000

  • 1st Hosp. of Shanxi Med Univ.

    Taiyuan, Shanxi, 030000

  • Shanxi Cardiovascular Hosp.

    Taiyuan, Shanxi, 030000

  • Taiyuan Central Hosp.

    Taiyuan, Shanxi, 030000

  • Tangshan Gongren Hosp.

    Tangshan, Hebei, 063000

  • No.254 Hosp. of PLA

    Tianjin, Tianjin Municipality, 300000

  • Tianjin CAPF Hosp.

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Chest Hosp.

    Tianjin, Tianjin Municipality, 300000

  • Tianjin No.3 Hosp.

    Tianjin, Tianjin Municipality, 300000

  • Tianjin People's Hosp.

    Tianjin, Tianjin Municipality, 300000

  • Wuhan Asican Heart Hosp.

    Wuhan, Hubei, 430000

  • Wuhan General Hosp of PLA

    Wuhan, Hubei, 430000

  • 2 nd Hosp. of Xi'an Med Col.

    Xi’an, Shanxi, 710000

  • Shanxi General Hosp. of CAPF

    Xi’an, Shanxi, 710000

  • Shanxi General Hosp.

    Xi’an, Shanxi, 710000

  • Tangdu Hosp.

    Xi’an, Shanxi, 710000

  • Xijing Hosp.

    Xi’an, Shanxi, 710000

  • Xuzhou Med Col. Affiliated Hosp.

    Xuzhou, Jiangsu, 221000

  • Xuzhou No.4 Hosp.

    Xuzhou, Jiangsu, 221000

  • Yanan Univ. affiliated Hosp.

    Yanan, Shanxi, 716000

  • Yantaishan Hosp.

    Yantai, Shandong, 261400

  • General Hosp. of Ningxia MU

    Yinchuan, Ningxia, 750000

  • Yingkou Centeral Hosp.

    Yingkou, Liaoning, 115000

  • Yuncheng Central Hosp.

    Yuncheng, Shanxi, 044000

  • No. 148 Hosp.

    Zibo, Shandong, 255000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Bivalirudin, heparin, heparin plus tirofiban
Keywords
Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BivalirudinDrug

    Also called Taijianing

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

  • heparinDrug

    heparin monotherapy

  • heparin plus tirofibanDrug

    Also called brand name of tirofiban: Xinweining

    combined use of heparin and tirofiban during PCI

Study groups in NCT01696110
Study groupRoleWhat they receive
BivalirudinExperimentalBivalirudin 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.
Receives: Drug: Bivalirudin
Heparin monotherapyActive comparator100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given.
Receives: Drug: heparin
heparin plus tirofibanActive comparatorheparin 60 IU/kg intravenous bolus and Tirofiban: 10μg/kg intravenous bolus followed by 0.15μg/kg per min infusion for up to 36h.
Receives: Drug: heparin; Drug: heparin plus tirofiban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Net Adverse Clinical Events

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

    Measured: 30 days

Secondary outcomes (3)

  1. Net adverse clinical events

    a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings

    Measured: 1 year

  2. any bleedings (BARC class)

    including all BARC class (class 1-5)

    Measured: 30 day

  3. Major adverse cardiac and cerebral events (MACCE)

    a composite of all cause death, reinfarction, target vessel revascularization or stroke

    Measured: 30 days and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJul 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01696110
Sponsor's protocol ID
SYNH20120001
Other IDs
2011BAI11B07
Acronym
BRIGHT
Status last verified
Sep 2014
First submitted
22 Aug 2012
Last updated
1 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26762481

  • 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.

    PubMed 25775052

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bivalirudin, heparin and heparin plus tirofiban in people with Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Shenyang Northern Hospital at 81 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Adverse Clinical Events (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01696110, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.

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