Acute Myocardial InfarctionPhase 3NCT02897037
Bivalirudin in Acute Myocardial Infarction
A Phase 3 study testing Bivalirudin and heparin in people with Acute Myocardial Infarction, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES. This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- 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
- 380 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years old
- Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB)
- Provide written informed consent.
Who cannot join
- Age <18 or >80 years.
- Any anticoagulant drugs were regularly used within 3 months.
- 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.
- Hemoglobin < 90 g/L or platelet count < 100 * 109 / L.
- Untreated or uncontrolled hypertension > 180/110 mmHg.
Show all 14Show fewer
- Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR < 30 mL/min / 1.73 m2).
- Heparin induced thrombocytopenia.
- Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
- Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- Pregnancy , lactation or plan to be pregnant.
- Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time < 6 months.
- Unsuitable for PCI.
- Attended any clinical trial 1 month before randomised.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology，General Hospital of Shenyang Military Region
Shanyang, Liaoning, 110016
Zhenyang Liang, Dr., 86-13332457575, doctorliangzi@sina.com
Yi Li, doctorliyi@126.com
About this study
Official title: Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial
The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.
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 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Bivalirudin, heparin
- 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
Also called Gansu
heparin monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Clinical Events
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
Measured: 30 days
Secondary outcomes (2)
Major adverse cardiac events (MACE)
A composite of all cause death, reinfarction, target vessel revascularization or stroke
Measured: 30 days
Any bleedings (BARC class)
Including all BARC class (class 3-5)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897037
- Sponsor's protocol ID
- Bright2
- Status last verified
- Nov 2016
- First submitted
- 7 Sep 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02897037
- Acronym / sponsor ID
- Bright2
- Conditions
- Acute Myocardial Infarction
- Keywords
- Bivalirudin, Acute myocardial infarction, percutaneous transluminal coronary angioplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Sep 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.
The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.
Detailed description
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Experimental | Drug: BivalirudinBivalirudin 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. |
| Heparin monotherapy | Active comparator | Drug: heparin100 IU/kg intravenous bolus. If ACT <225s 5 min after bolus injection, additional dose of heparin (20U/kg) will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 80 years old
- Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB)
- Provide written informed consent.
Key exclusion criteria (14 listed)
- Age <18 or >80 years.
- Any anticoagulant drugs were regularly used within 3 months.
- 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.
- Hemoglobin < 90 g/L or platelet count < 100 * 109 / L.
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 |
|---|---|---|
| BivalirudinAlso: TaijianingPatients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation. | Drug | Bivalirudin |
| heparinAlso: Gansuheparin monotherapy | Drug | Heparin monotherapy |
Primary outcome
Net Adverse Clinical Events
Time frame: 30 days
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
2 secondary outcomes
Major adverse cardiac events (MACE)
Time frame: 30 days
Any bleedings (BARC class)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bivalirudin and heparin in people with Acute Myocardial Infarction, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jiangjing Long, Dr. (86-10-58696282 ext. 840, longjianjing@salubris.cn), or a site near the patient. 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?
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 28 Nov 2016.