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Table 1 Inclusion criteria of the REACT trial

From: The REACT study: design of a randomized phase 3 trial to assess the efficacy and safety of clazosentan for preventing deterioration due to delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage

- Written informed consent to participate in the study must be obtained from the patient or proxy / legal representative at any time from hospital admission to prior to initiation of any study-mandated procedure.

- Males and females 18 to 70 years of age (inclusive, at hospital admission)

- Patients with a ruptured saccular aneurysm, angiographically confirmed by DSA or CTA, which has been successfully secured within 72 hours of rupture by surgical clipping or endovascular coiling.

- WFNS grades 1–4 (based on GCS) assessed after recovery from the aneurysm-securing procedure and after external ventricular drainage for hydrocephalus, if required

- Presence of a thick and diffuse clota on the hospital admission CT scan, absence of cerebral vasospasm at the time of randomization, and possibility to start study drug in the ICU (or equivalent environment where all protocol assessments can be performed and the Patient Management Guidelines followed) within 96 hours following the time of the aneurysm rupture.

- Presence of a cerebral CT scan performed at least 8 hours post aneurysm-securing procedure and within 24 hours prior to randomization.

- Absence of a significant (e.g., symptomatic or large) new or worsened cerebral infarct or re-bleeding of the repaired aneurysm on the post-procedure CT scan.

- A woman of childbearing potential is eligible only if the pregnancy test performed during the screening period is negative. Agreement must be obtained to take the necessary precautions to avoid pregnancy from hospital discharge until 30 days post-study drug discontinuation. If breastfeeding, agreement must be obtained to refrain for the duration of the treatment with study drug and until 30 days post-study drug discontinuation.

- Males are eligible for study participation only if they agree to take the necessary precautions to avoid pregnancy in a female partner from hospital discharge until 30 days post-study drug discontinuation.

  1. CTA computed tomography (angiogram), DSA digital subtraction angiogram, GCS Glasgow Coma Scale, ICU intensive care unit, WFNS World Federation of Neurological Societies
  2. aDefined as a thick confluent clot, more than 4 mm in thickness, involving 3 or more basal cisterns