Coronary DiseasePhase 4NCT02787317
Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
A Phase 4 study testing bivalirudin and Heparin in people with Coronary Disease, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- bivalirudin and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,770 participants
- Where
- 2 sitesChina
- Study dates
- May 2016to Nov 2018
- 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
- Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.
Who cannot join
- cardiogenic shock;
- thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization;
- active or recent major bleeding or bleeding predisposition;
- major surgery within 1 month;
- clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis;
- blood pressure higher than 180/110 mm Hg;
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- known hemoglobin less than 10 g/dL, platelet count less than 100 × 109/L, aminotransferase level greater than 3 × the upper limit of normal, or creatinine clearance less than 30 mL/min;
- history of heparin-induced thrombocytopenia;
- allergy to any of the study drugs or devices;
- pregnancy or lactation;
- any condition making PCI unsuitable or that might interfere with study adherence; and
- patient unwilling or unable to provide written informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites
ChinaPLAGH
Beijing, Beijing Municipality, 1000853
ChinaPLAGH
Beijing, Beijing Municipality, 100853
yundai chen, 08601055499309, dingyutinkle@163.com
About this study
Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
Read the detailed description
Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
- Conditions
- Coronary Disease
- Being tested
- bivalirudin, Heparin
- Keywords
- bivalirudin, myocardial injure
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalirudinDrug
Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
HeparinDrug
Heparin is used in patients undergoing percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| heparin | Active comparator | For the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines. Receives: Drug: Heparin |
| not prolong infusion Bivalirudin | Experimental | Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure . Receives: Drug: bivalirudin |
| prolong infusion bivalirudin | Experimental | Bivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure. Receives: Drug: bivalirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatine kinase-MB increase
creatine kinase-MB increase >3 times upper limit of normal
Measured: up to postprocedural 72 hours
Secondary outcomes (3)
bleeding（BARC class）
including BARC class 2-5
Measured: 30 days and 1 year
major adverse cardiac or cerebral events
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Measured: 30 days and 1 year
Net Adverse Clinical Events
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleeding
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.
- First posted1 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 1,770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787317
- Sponsor's protocol ID
- ChinaPLA general hospital
- Status last verified
- May 2016
- First submitted
- 24 May 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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 25775052Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.
PubMed 19801025
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI
- ClinicalTrials.gov ID
- NCT02787317
- Acronym / sponsor ID
- ChinaPLA general hospital
- Conditions
- Coronary Disease
- Keywords
- bivalirudin, myocardial injure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,770 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
Detailed description
Bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease. Prolonging infusions may decrease myocardial damage associated with bivalirudin use during primary PCI . However, whether prolonging infusions of bivalirudin could prevent ischemic complications is unknown. The investigators examined the effects of prolonged drug infusion after elective PCI. The investigators hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose for 4 hours would prevent myocardial damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| heparin | Active comparator | Drug: HeparinFor the heparin group, a bolus dose of 100 U/kg was administered according to current guidelines. |
| not prolong infusion Bivalirudin | Experimental | Drug: bivalirudinBivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure . |
| prolong infusion bivalirudin | Experimental | Drug: bivalirudinBivalirudin was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and prolong for 4 hours after procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 80 years with stable ischemic heart disease in whom PCI was required.
Key exclusion criteria (12 listed)
- cardiogenic shock;
- thrombolytic therapy administered before randomization or any anticoagulant administered within 48 hours of randomization;
- active or recent major bleeding or bleeding predisposition;
- major surgery within 1 month;
- clinical syndrome suspicious for aortic dissection, pericarditis, or endocarditis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bivalirudinBivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention. | Drug | not prolong infusion Bivalirudin, prolong infusion bivalirudin |
| HeparinHeparin is used in patients undergoing percutaneous coronary intervention. | Drug | heparin |
Primary outcome
creatine kinase-MB increase
Time frame: up to postprocedural 72 hours
creatine kinase-MB increase >3 times upper limit of normal
3 secondary outcomes
bleeding（BARC class）
Time frame: 30 days and 1 year
major adverse cardiac or cerebral events
Time frame: 30 days and 1 year
Net Adverse Clinical Events
Time frame: 30 days and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Background: PubMed 25775052Han 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 publication: PubMed 19801025Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bivalirudin and Heparin in people with Coronary Disease, run by Chinese PLA General Hospital at 2 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yundai chen, doctor (+08613581886786, dingyutinkle@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
creatine kinase-MB increase (time frame: up to postprocedural 72 hours). 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 NCT02787317, 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 Jun 2016.