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NCT04532333·Phase 3·INTERVENTIONAL

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

BivalirudinOtherUnknown

Status

Unknown

Phase

Phase 3

Enrollment

236

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Bivalirudin 250 MG Injection

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

Heparin

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

Timeline

From registration to results.

  1. First posted

    Aug 31, 2020

  2. Study start

    Aug 2020

  3. Primary completion

    May 2021

  4. Study completion

    Jun 2021

  5. Results posted

    Not reported

  6. Registry updated

    Aug 31, 2020

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Modified Rankin Scale (mRS)

Time frame · 30 days

The mRS score, and proportion of subjects achieving mRS score of 0-2

Activated Clotting Time (ACT)

Time frame · During procedure

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

Procedure-related complication

Time frame · During procedure, at 24hs, 7days

A composite of of death from any cause, thromboembolic events, or bleeding defined by BARC definition 3 or 5 BARC=Bleeding Academic Research Consortium

Thromboembolic events

Time frame · During procedure, at 24hs, 7days, 30days

Definition: 1. Intraoperative: stent thrombosis/stenosis, distal vascular occlusion on imaging 2. 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

Bleeding events

Time frame · During procedure, at 24hs, 7days, 30days

Any bleeding as defined by the BARC definition (except grade 4) Any bleeding as defined by the GUSTO definition

Intracranial hemorrhage

Time frame · During procedure, at 24hs, 7days, 30days

Intracranial hemorrhage and Symptomatic intracranial hemorrhage

Heparin-induced thrombocytopenia(HIT)

Time frame · 7days

defined as a platelet count decrease ofmore than50%or more than 150 × 109/L frombaseline

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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