Efficacy and Safety of Bivalirudin Versus Heparin During Coil Embolization in Patients With Ruptured Intracranial Aneurysms

NCT04532333 | Unknown Phase 3 DMC

• 1 other identifier: CHEC2020-042
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

Anticoagulant Agents; Aneurysm, Intracranial Berry; Therapeutic Embolization; Anticoagulation Agents; Heparin Sodium; Bivalirudin

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (7)

• Modified Rankin Scale (mRS)

  30 days

• Activated Clotting Time (ACT)

  During procedure

• Procedure-related complication

  During procedure, at 24hs, 7days

• Thromboembolic events

  During procedure, at 24hs, 7days, 30days

• Bleeding events

  During procedure, at 24hs, 7days, 30days

Study Arms (2)

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

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.

Drug: Heparin

Interventions

Bivalirudin 250 MG Injection DRUG

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

Bivalirudin

Heparin DRUG

Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after.

Heparin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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..
• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Zhejiang University: collaborator
• Wuhan University: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First People's Hospital of Changzhou: collaborator

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm

Interventions

bivalirudin; Injections; Heparin

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jianmin Liu, M.D.

  Neurosurgical Department of Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Sheng Guan, M.D.

  Neurointerventional Department, The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Zhao, Doctor

CONTACT

+86-13916728169; z_ray1979@126.com

Qiao Zuo, Doctor

CONTACT

+86-13621817430; dr_zuo@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Neurosurgical Department,Changhai Hospital,Shanghai,China

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: August 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 31, 2020

Record last verified: 2020-08