Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

The investigators propose to conduct a multicenter randomized trial to test whether cilostazol reduces the incidence of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) and improves patients' neurological prognosis, while assessing its safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-80 years.

Diagnosed with subarachnoid hemorrhage (SAH) by computed tomography (CT) scan, and the responsible aneurysm is clearly identified by computed tomography angiography (CTA) or digital subtraction angiography (DSA).

Received aneurysm coil embolization or craniotomy clipping within 72 hours of symptom onset.

Hunt-Hess grade II-IV.

Disqualifiers

Multiple aneurysms (>1aneurysms confirmed by CTA/DSA)

Modified Rankin Scale (mRS) score ≥ 3 before onset

Allergy to cilostazol

Severe heart failure(New York Heart Association (NYHA) Functional Classification Grade III or IV)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cilostazol 100 mg BID

    Drug

    Within 24 hours after randomization, patients will receive cilostazol 100 mg twice daily (BID) for 14 consecutive days, in addition to the standard aSAH treatment.

  • placebo

    Drug

    Within 24 hours after randomization, patients will receive a placebo twice daily (BID) for 14 consecutive days, in addition to the standard aSAH treatment.

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: Cilostazol GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of delayed cerebral ischemia (DCI)

Delayed cerebral ischemia (DCI) was defined as the occurrence of clinical deterioration, including new-onset focal neurological deficits (e.g., hemiplegia, aphasia, apraxia, hemianopia, or neglect) and/or a decrease in the consciousness (a Glasgow Coma Scale \[GCS\] score reduction of at least 2 points, either in the total score or any individual subscore), with symptoms lasting for at least 1 hour and not occurring immediately after aneurysm surgery. Other potential causes of clinical deterioration (e.g., hydrocephalus, rebleeding, fever, infection, metabolic disturbance, epilepsy, etc.) were excluded. Alternatively, DCI was defined as the presence of new infarct lesions on follow-up brain CT/MRI that were not detected on the initial admission brain CT or post-operative follow-up brain CT.

Time frame
At 14±2 days after randomization

Secondary outcomes

1

Neurological function prognosis

The modified Rankin Scale (mRS) score and Glasgow Outcome Scale (GOS) score were evaluated at 90 days after randomization. Favorable outcome was defined as an mRS score of 0-3 (0-3 indicating no disability to moderate disability; 4-6 indicating moderately severe disability to death) and a GOS score of 3-5 (3-5 indicating severe disability to good recovery).

Time frame
At 90 days after randomization
2

Incidence of intracranial rebleeding events

Any new intracranial hemorrhage occurring within 90 days after randomization (whether rebleeding in the surgical area or new intracranial hemorrhage events following cilostazol administration), confirmed by comparing non-contrast CT scan results during follow-up with those of the last post-operative non-contrast CT scan before randomization.

Time frame
At 90±7 days after randomization
3

Incidence of other severe bleeding events

Any new symptomatic intracranial hemorrhage or any new moderate or severe hemorrhage occurring within 90 days after randomization (defined according to the Bleeding Academic Research Consortium \[BARC\] criteria as hemorrhage requiring endoscopic treatment, surgical intervention, or blood transfusion \[Types 2-3\] and fatal hemorrhage \[Type 5\]).

Time frame
At 90 days after randomization

Other outcomes

Sponsors and contacts

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