Subarachnoid Hemorrhage, AneurysmalPhase 3BUILDNCT04532333
Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms
A Phase 3 study testing Bivalirudin 250 MG Injection and Heparin in people with Subarachnoid Hemorrhage, Aneurysmal, run by Changhai Hospital.
Trial summary
This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Bivalirudin 250 MG Injection and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, any gender
- intracranial aneurysms ruptured in 14 days
- Diagnosed as subarachnoid hemorrhage (SAH) by CT, confirmed aneurysmal SAH by DSA
- Hunt-Hess I-III
- Patient is suitable for coil embolization
- Informed consent and availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements
Who cannot join
- Nonsaccular Aneurysms (include infective, fusiform, dissecting aneurysms)
- Prior intracranial aneurysms
- Poor baseline of mRS 4-5
- Aneurysms that cannot be successfully treated by interventional treatment judged by clinician.
- Patients cannot receive antiplatelet aggregation or anticoagulant therapy
- Patients with indications for emergency craniotomy: intracranial hematoma, high intracranial pressure or hydrocephalus etc..
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- Patients with AVM, intracranial artery stenosis or moyamoya disease
- Pregnancy or lactation
- Patients with severe abnormal function of main organs, liver or kidney
- Other serious diseases not suitable for this study
- Patients are currently participating in another drug-related clinical study
- Patients are allergic to heparin or bivalirudin and its excipients or hirudin
- Patients with a clear history of allergy to coil embolic material
- Patients had or may have had severe reactions to contrast media that could not complete the preoperative medication
- Patients are not suitable to participate in this clinical study judged by clinician
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anticoagulant Efficacy and Safety of BivalirUdin Versus heparIn During coiL Embolization in Patients With ruptureD Intracranial Aneurysms: an Open-label, Multicenter, Randomized Pilot Study（BUILD）
This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms.
Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.
Read the detailed description
Endovascular embolization has become an effective modality for the treatment of intracranial aneurysms. Despite advances in technology and techniques, thromboembolic and bleeding events are still encountered as inherent perioperative complications. Hypercoagulability as a systemic response to acute subarachnoid hemorrhage (SAH) may be associated with an increased incidence of thromboembolic events.
The administration of anticoagulant may reduce thromboembolic events during the endovascular embolization, meanwhile, involves the risk of bleeding. Although heparin is commonly used during the procedure, the safety in patients with ruptured intracranial aneurysms has not been established. In contrast to heparin, bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding and an overall favorable profile. Bivalirudin administration in patients with high bleeding risk during coronary intervention is recommended by current guidelines.
This is an open label, multicenter, randomized pilot study, which is aimed to investigate the safety and efficacy of bivalirudin coil embolization in patients with ruptured intracranial aneurysms.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Bivalirudin 250 MG Injection, Heparin
- Keywords
- Anticoagulant Agents, Aneurysm, Intracranial Berry, Therapeutic Embolization, Anticoagulation Agents, Heparin Sodium, Bivalirudin
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalirudin 250 MG InjectionDrug
Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure
HeparinDrug
Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after.
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Experimental | Bivalirudin at full dose Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure Receives: Drug: Bivalirudin 250 MG Injection |
| Heparin | Active comparator | Heparin first dose at 0.6mg/kg(75U/kg) Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related complication
A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium
Measured: 30 days
Secondary outcomes (7)
Modified Rankin Scale (mRS)
The mRS score, and proportion of subjects achieving mRS score of 0-2
Measured: 30 days
Activated Clotting Time (ACT)
ACT values of 0 min and 5 min after bolus injection will be recorded in all patients Extra ACT values of 15 min, 30 min, 55min, 65 min,and 115 min after bolus injection will be recorded in 8 patients of both arm, and the curve will be simulated
Measured: During procedure
Procedure-related complication
A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium
Measured: During procedure, at 24hs, 7days
Thromboembolic events
Definition:
- Intraoperative: stent thrombosis/stenosis, distal vascular occlusion on imaging
- Postoperative： 1) new deficits or change in level of consciousness, intracranial hemorrhage cause is excluded by CT, 2) no clinical symptom but CT showed new infarction
Measured: During procedure, at 24hs, 7days, 30days
Bleeding events
Any bleeding as defined by the BARC definition (except grade 4) Any bleeding as defined by the GUSTO definition
Measured: During procedure, at 24hs, 7days, 30days
Intracranial hemorrhage
Intracranial hemorrhage and Symptomatic intracranial hemorrhage
Measured: During procedure, at 24hs, 7days, 30days
Heparin-induced thrombocytopenia(HIT)
defined as a platelet count decrease ofmore than50%or more than 150 × 109/L frombaseline
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Changhai 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Zhejiang University, Wuhan University, Qilu Hospital of Shandong University, The First People's Hospital of Changzhou
- Responsible party
- Principal investigator, Jian-min Liu, Changhai Hospital
- Investigators
- Jianmin Liu, M.D., Principal investigator, Neurosurgical Department of Changhai HospitalSheng Guan, M.D., Principal investigator, Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532333
- Sponsor's protocol ID
- CHEC2020-042
- Acronym
- BUILD
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulant Efficacy and Safety of BivalirUdin Versus heparIn During coiL Embolization in Patients With ruptureD Intracranial Aneurysms: an Open-label, Multicenter, Randomized Pilot Study（BUILD）
- ClinicalTrials.gov ID
- NCT04532333
- Acronym / sponsor ID
- BUILD / CHEC2020-042
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Anticoagulant Agents, Aneurysm, Intracranial Berry, Therapeutic Embolization, Anticoagulation Agents, Heparin Sodium, Bivalirudin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Zhejiang University, Wuhan University, Qilu Hospital of Shandong University, The First People's Hospital of Changzhou
- Study start
- Aug 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 31 Aug 2020 (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.
This is a randomized, open label, multi-center, positive-controlled study, in which a total of 236 patients will be enrolled and randomly assigned to receive bivalirudin or heparin in a 1:1 ratio during coil embolization in patients with ruptured intracranial aneurysms.
Procedure-related complication, mRS, Activated Clotting Time, ischemic and hemorrhagic complications, symptomatic and asymptomatic intracranial hemorrhage, death, Heparin Induced Thrombocytopenia will be evaluated during procedure, at 24hs, 7days and 30 days after.
Detailed description
Endovascular embolization has become an effective modality for the treatment of intracranial aneurysms. Despite advances in technology and techniques, thromboembolic and bleeding events are still encountered as inherent perioperative complications. Hypercoagulability as a systemic response to acute subarachnoid hemorrhage (SAH) may be associated with an increased incidence of thromboembolic events.
The administration of anticoagulant may reduce thromboembolic events during the endovascular embolization, meanwhile, involves the risk of bleeding. Although heparin is commonly used during the procedure, the safety in patients with ruptured intracranial aneurysms has not been established. In contrast to heparin, bivalirudin is a short-lived direct thrombin inhibitor with an intrinsic antiplatelet activity and more stable pharmacokinetic and pharmacodynamic properties which has been associated with reduced bleeding and an overall favorable profile. Bivalirudin administration in patients with high bleeding risk during coronary intervention is recommended by current guidelines.
This is an open label, multicenter, randomized pilot study, which is aimed to investigate the safety and efficacy of bivalirudin coil embolization in patients with ruptured intracranial aneurysms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Experimental | Drug: Bivalirudin 250 MG InjectionBivalirudin at full dose Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure |
| Heparin | Active comparator | Drug: HeparinHeparin first dose at 0.6mg/kg(75U/kg) Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 80 years, any gender
- intracranial aneurysms ruptured in 14 days
- Diagnosed as subarachnoid hemorrhage (SAH) by CT, confirmed aneurysmal SAH by DSA
- Hunt-Hess I-III
- Patient is suitable for coil embolization
Key exclusion criteria (15 listed)
- Nonsaccular Aneurysms (include infective, fusiform, dissecting aneurysms)
- Prior intracranial aneurysms
- Poor baseline of mRS 4-5
- Aneurysms that cannot be successfully treated by interventional treatment judged by clinician.
- Patients cannot receive antiplatelet aggregation or anticoagulant therapy
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 |
|---|---|---|
| Bivalirudin 250 MG InjectionBivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure | Drug | Bivalirudin |
| HeparinHeparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after. | Drug | Heparin |
Primary outcome
Procedure-related complication
Time frame: 30 days
A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium
7 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: 30 days
Activated Clotting Time (ACT)
Time frame: During procedure
Procedure-related complication
Time frame: During procedure, at 24hs, 7days
Thromboembolic events
Time frame: During procedure, at 24hs, 7days, 30days
Bleeding events
Time frame: During procedure, at 24hs, 7days, 30days
Intracranial hemorrhage
Time frame: During procedure, at 24hs, 7days, 30days
Heparin-induced thrombocytopenia(HIT)
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- 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.
Jianmin Liu, M.D. principal investigator
Neurosurgical Department of Changhai Hospital
Sheng Guan, M.D. principal investigator
Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bivalirudin 250 MG Injection and Heparin in people with Subarachnoid Hemorrhage, Aneurysmal, run by Changhai Hospital.
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 6 inclusion and 15 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Rui Zhao, Doctor (+86-13916728169, z_ray1979@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related complication (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 31 Aug 2020.