Tirofiban for Brain Aneurysm

(iSPASM-2 Trial)

Not yet recruiting at 1 trial location
HB
BP
Overseen ByBeth Perry

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment using tirofiban for individuals who have experienced a brain bleed from a ruptured aneurysm treated with endovascular coiling. The researchers aim to determine the safest dose and assess whether it helps prevent issues like delayed brain damage or blood vessel spasms. Participants will receive either tirofiban or a placebo through an IV for up to a week. Suitable candidates for this trial are those who recently had an aneurysm-induced brain bleed and underwent a specific coiling procedure. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you need to continuously use aspirin, clopidogrel, ticagrelor, or tirofiban during the study.

Is there any evidence suggesting that tirofiban is likely to be safe for humans?

Research has shown that tirofiban is generally safe for treating brain aneurysms. Studies indicate that using tirofiban during procedures like stent-assisted coiling of ruptured aneurysms is both feasible and safe. For instance, one study found it did not increase the risk of bleeding. Another study reported a low risk of serious issues like bleeding or clots with tirofiban. While some reports mention minor risks, tirofiban is well-tolerated and does not significantly raise the risk of bleeding. Overall, evidence suggests tirofiban is safe for short-term use in similar treatments.12345

Why do researchers think this study treatment might be promising?

Tirofiban is unique because it offers a new approach to treating brain aneurysms by targeting platelet aggregation, which is not the primary focus of traditional treatments. Most current options, like surgical clipping or coiling, physically address the aneurysm itself but do not modify the underlying blood clotting processes. By using tirofiban, an antiplatelet agent, researchers hope to reduce the risk of clot-related complications after endovascular coiling. This could potentially enhance recovery by preventing the formation of harmful blood clots, offering a novel layer of protection that standard mechanical methods do not provide.

What evidence suggests that tirofiban might be an effective treatment for aneurysmal subarachnoid hemorrhage?

Research has shown that tirofiban is safe and effective for treating brain aneurysms. Studies have found that it can lower the risk of blood clots without increasing bleeding problems. In this trial, participants will receive either a continuous IV infusion of tirofiban or a saline placebo for 1, 3, 5, or 7 days after endovascular coiling. Previous studies have demonstrated that patients using tirofiban experienced better recovery outcomes, meaning they were more likely to improve from their condition. Specifically, another study showed that tirofiban significantly reduced blood clot-related issues compared to other treatments. Overall, these findings suggest that tirofiban could be a promising option for enhancing recovery in patients with brain aneurysms.12678

Who Is on the Research Team?

EH

Emad Hasan, MD

Principal Investigator

Duke University

BM

Brian Mac Grory, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who recently had a brain bleed from a ruptured aneurysm, treated with endovascular coiling. They must be in stable condition, able to consent (or have a representative), and meet specific scan and timing criteria after their treatment.

Inclusion Criteria

* Admission Computed Tomography (CT) scan shows Modified Fisher grade 1-4 due to aSAH primarily in the supratentorial space
* If External Ventricular Drain (EVD) placed, placement is ≥12 hours prior to enrollment
All my aneurysms causing bleeding have been treated with coil embolization and are secure.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive continuous IV infusion of tirofiban or placebo for 1, 3, 5, or 7 days to determine the maximum tolerated dosage

1-7 days
Daily monitoring during infusion

Cohort Expansion

Participants are randomized to receive tirofiban at MTD or placebo to achieve balanced sample sizes

Varies based on infusion duration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pharmacokinetic and pharmacodynamic analysis

Up to 6 months
Regular follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Tirofiban

Trial Overview

The study compares an intravenous drug called tirofiban to a placebo in people recovering from aneurysmal subarachnoid hemorrhage. It aims to find the highest safe dose of tirofiban and see how it affects blood vessel spasms and recovery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TirofibanExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr David Hasan, M.D.

Lead Sponsor

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Safety and efficacy of intravenous tirofiban for stent-assisted ...

Tirofiban appears to be a safe and alternative during the stent-assisted coiling of ruptured intracranial aneurysms.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39871064/

Safety and efficacy of tirofiban in the endovascular ...

This systematic review and meta-analysis demonstrate that the use of tirofiban during endovascular treatment of IA is both feasible and safe.

The Prophylactic Use of Tirofiban versus Oral Antiplatelet ...

Prophylactic therapy with tirofiban resulted in significantly lower rates of thromboembolic complications with no increase in hemorrhagic events or mortality.

Effect of Intravenous Tirofiban Versus Placebo on First‐ ...

FPSR was achieved more often in the tirofiban group (30.5% versus 23.5%; adjusted risk ratio, 1.24 [95% CI, 1.01–1.51]; P=0.04). FPSR was ...

Efficacy and safety of intravenous tirofiban versus standard ...

Tirofiban increases the number of patients achieving a favorable functional outcome in patients. There was no improvement in NIHSS after 24 hours and 7 days.

Safety and efficacy of short-term tirofiban combined with ...

Tirofiban combined with DAPT in flow diverter treatment for intracranial aneurysms demonstrated good safety without increasing bleeding risk, though its ...

Safety and efficacy of prophylactic tirofiban infusion for ...

Tirofiban prophylactic infusion can lower the incidence of AIST, without increasing the risk of periprocedural intracranial hemorrhage and 30-day total ...

Safety and Efficacy of Intravenous Tirofiban as Antiplatelet ...

CONCLUSIONS: In our study, tirofiban showed a low risk of symptomatic hemorrhagic or thromboembolic complications. Tirofiban may offer a safe ...