Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding RiskPhase 4NCT04195997
Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion
A Phase 4 study testing Bivalirudin and Heparin in people with Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in patients with non-valvular atrial fibrillation undergoing percutaneous left atrial appendage occlusion. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk
- What is being tested?
- Bivalirudin and Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 30 Jun 2021
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 60 years;
- non-valvular atrial fibrillation patients with contraindication for long-term oral anticoagulant or occurrence or stroke in spite of regular administration of medication;
- CHA2DS2 score≥2 and/or HAS-BLED score≥3;
- Provide written informed consent.
Who cannot join
- Left atrial diameter≥65mm;Severe mitral regurgitation；percardial effusion>3mm；LVEF<35%;
- Peri-procedual thrombus in left atrial and/or left atrial appendage confirmed by TEE;
- Other comorbidities requiring for use of anticoagulants.
- Life expectancy ≥ 1 year;
- CHA2DS2 score ≤1 and HAS-BLED score≤2;
- Active bleeding or bleeding constitution, bleeding tendency, including GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc;
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- Other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.);
- Severe renal insufficiency (eGFR < 30 mL/min/ 1.73 m2); Elevated AST, ALT level higher than three times of the normal upper limit; Advanced heart failure (NYHA classification grading of cardiac function ≥ Ⅲ) Complicated with immune system diseases；
- Abnormal hematopoietic system：platelet count < 100 * 109 / L or > 700 * 109 / L，white blood cell count < 3 * 109/L etc;
- Suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors;
- Known intolerance, or contraindication to any antithrombotic medication Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
- Non-cardiac co-morbid conditions are present that may result in protocol non-compliance;
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
- Patient's inability to fully cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hopital of Fudan University
Shanghai, Shanghai Municipality, 200032
XIAOCHUN ZHANG, MD
About this study
Official title: Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion
The study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in patients with non-valvular atrial fibrillation undergoing percutaneous left atrial appendage occlusion.
Read the detailed description
Bivalirudin, a direct thrombin inhibitor, emerged as an important representative of intravenous anticoagulant and has been recommended for treatment of acute coronary syndromes with percutaneous coronary intervention according to American and European guidelines.On concerns of risk of bleeding and thrombosis,bivalirudin shows significant advantages over traditional glycoprotein inhibitors(GPI).However,the research about the application of bivalirudin for patients at high-risk of stroke and bleeding with non-valvular atrial fibrillation is still at blank stage.Percutaneous left atrial appendage occlusion is nowadays an effective alternative for stroke prevention and its targeted population is featured as CHA2DS2 score≥2 and/or HAS-BLED score≥3.The purpose of this multi-center trial is to evaluate the safety and peri-procedual efficacy of bivalirudin for patients at high-risk atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion.
- Being tested
- Bivalirudin, Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
HeparinDrug
heparin during left atrial appendage occlusion.
| Study group | Role | What they receive |
|---|---|---|
| bivalurudin | Experimental | Bivalirudin will be given as a bolus of 0.75 mg/kg once transseptal puncture is successully performed with no pericardial effusion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds. Receives: Drug: Bivalirudin |
| heparin | Active comparator | Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
a composite of all cause death, stroke
Measured: 7 days
Major bleeding
BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Measured: 7 days
Secondary outcomes (4)
Creatine kinase-MB increase
creatine kinase-MB increase >3 times upper limit of normal
Measured: up to postprocedural 72 hours
Major bleeding
BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
Measured: 60 days
Major adverse cardiac events
a composite of all cause death, stroke，heart failure
Measured: 60 days
Device-related thrombus
rate of stent thrombosis
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Feb 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding RiskStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XIAOCHUN ZHANG, MD, Principal investigator, Department of Cardiology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195997
- Sponsor's protocol ID
- ZS-2018-81
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT04195997
- Acronym / sponsor ID
- ZS-2018-81
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 12 Dec 2019 (actual)
- 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 study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in patients with non-valvular atrial fibrillation undergoing percutaneous left atrial appendage occlusion.
Detailed description
Bivalirudin, a direct thrombin inhibitor, emerged as an important representative of intravenous anticoagulant and has been recommended for treatment of acute coronary syndromes with percutaneous coronary intervention according to American and European guidelines.On concerns of risk of bleeding and thrombosis,bivalirudin shows significant advantages over traditional glycoprotein inhibitors(GPI).However,the research about the application of bivalirudin for patients at high-risk of stroke and bleeding with non-valvular atrial fibrillation is still at blank stage.Percutaneous left atrial appendage occlusion is nowadays an effective alternative for stroke prevention and its targeted population is featured as CHA2DS2 score≥2 and/or HAS-BLED score≥3.The purpose of this multi-center trial is to evaluate the safety and peri-procedual efficacy of bivalirudin for patients at high-risk atrial fibrillation patients undergoing percutaneous left atrial appendage occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bivalurudin | Experimental | Drug: BivalirudinBivalirudin will be given as a bolus of 0.75 mg/kg once transseptal puncture is successully performed with no pericardial effusion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds. |
| heparin | Active comparator | Drug: HeparinHeparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 60 years;
- non-valvular atrial fibrillation patients with contraindication for long-term oral anticoagulant or occurrence or stroke in spite of regular administration of medication;
- CHA2DS2 score≥2 and/or HAS-BLED score≥3;
- Provide written informed consent.
Key exclusion criteria (14 listed)
- Left atrial diameter≥65mm;Severe mitral regurgitation；percardial effusion>3mm；LVEF<35%;
- Peri-procedual thrombus in left atrial and/or left atrial appendage confirmed by TEE;
- Other comorbidities requiring for use of anticoagulants.
- Life expectancy ≥ 1 year;
- CHA2DS2 score ≤1 and HAS-BLED score≤2;
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 |
|---|---|---|
| BivalirudinPatients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion. | Drug | bivalurudin |
| Heparinheparin during left atrial appendage occlusion. | Drug | heparin |
Primary outcome
Major adverse cardiac events
Time frame: 7 days
a composite of all cause death, stroke
Major bleeding
Time frame: 7 days
BARC types 2-5 bleeding;TIMI major bleeding or GUSTO moderate to severe bleeding
4 secondary outcomes
Creatine kinase-MB increase
Time frame: up to postprocedural 72 hours
Major bleeding
Time frame: 60 days
Major adverse cardiac events
Time frame: 60 days
Device-related thrombus
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
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.
XIAOCHUN ZHANG, MD principal investigator
Department of Cardiology, Zhongshan Hospital, Fudan University
1 site 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 Evaluate the Safety and Efficacy of Bivalirudin in Decreasing Bleeding Risk, run by Shanghai Zhongshan Hospital 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 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: status not confirmed, as of the sponsor's last update on 12 Dec 2019. 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 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 XIAOCHUN ZHANG, MD (8615002121366, 514864787@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 7 days). The study lists 2 primary outcomes in all. 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 12 Dec 2019.