Phase 1/2a Trial of ISPASM(Induced Suppression of Platelets Activity in Aneurysmal SAH Management)

YOUR RESPONSIBILITY  is to ensure your  doctor and hospital initiates that  followup research. Or don't you want your children and grandchildren to have better care? And they still are measuring the wrong endpoint, the only goal in stroke is 100% recovery.  You have lots of work to do after this intermediate intervention to get to 100% recovery. WHAT THE FUCK IS YOUR STRATEGY TO GET THERE?

 

Phase 1/2a Trial of ISPASM(Induced Suppression of Platelets Activity in Aneurysmal SAH Management)

Mario Zanaty

,

Lauren Allan

,

Edgar A. Samaniego

,

Anthony Piscopo

,

Eleanor Ryan

,

James C. Torner

,

David Hasan

Originally published2 Sep 2021https://doi.org/10.1161/STROKEAHA.121.034578Stroke. ;0:STROKEAHA.121.034578

Abstract

Background and Purpose:

Microthrombosis could play a role in delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Tirofiban has shown promising results in reducing delayed cerebral ischemia in retrospective studies. However, the safety of using tirofiban in aneurysmal subarachnoid hemorrhage is not rigorously established.

Methods:

A phase 1/2a double-blinded randomized controlled trial (2:1 randomization) to assess the safety of a 7-day intravenous infusion of tirofiban compared with placebo, in patients with aneurysmal subarachnoid hemorrhage treated with ventriculostomy placed in the operative room and coiling was conducted. The primary end point was any intracranial hemorrhage during the hospital stay. The secondary end points were: incidence of radiographic and clinical vasospasm, incidence of delayed cerebral ischemia, and incidence of cerebral ischemic changes noted on magnetic resonance imaging or computed tomography.

Results:

Eighteen patients received intravenous tirofiban and 12 received placebo. There was no difference in baseline characteristics except for higher male proportions in the tirofiban group. There was no difference in death, in development of new or change in existing intracranial hemorrhages, in thrombocytopenia, and need for shunts in the two arms. However, the tirofiban arm had a lower incidence of delayed cerebral ischemia compared with placebo (6% [1/18] versus 33% [4/12]; P=0.04), and less radiographic vasospasm as detected by catheter angiogram or computed tomography angiography (P=0.01) and computed tomography perfusion (P=0.01).

Conclusions:

The above preliminary results j of the safety and efficacy of 7-day intravenous infusion of tirofiban in a pragmatic (placing external ventricular drain by the bedside), multicenter setting, and using a larger population.

REGISTRATION:

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03691727.

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