Cilostazol for Preventing Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage (CAPTAIN)

Capital Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Drug: Cilostazol 100 mg BID; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07249853

CAPTAIN

Details and patient eligibility

About

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.

Full description

The investigators propose to conduct a multicenter randomized trial to test the primary hypothesis of whether cilostazol reduces the incidence of delayed cerebral ischemia (DCI) following aneurysmal subarachnoid hemorrhage (aSAH) and improves patients' neurological prognosis, while assessing its safety. The investigators will recruit 316 patients from 30 hospitals in China. Eligibility criteria for the trial participants include Aged 18-80 years. Diagnosed with subarachnoid hemorrhage (SAH) by computed tomography (CT) scan, and the responsible aneurysm is 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. No rebleeding or new intracranial hemorrhage is shown on head CT within 6 hours after surgery. Understand and follow the procedures of clinical trial, participate voluntarily and sign the informed consent (the informed consent can be signed voluntarily by the person or guardian). Patients with multiple aneurysms, Modified Rankin Scale (mRS) score ≥ 3 before onset, contraindications to cilostazol use, severe organic diseases and an expected survival time of less than 90 days, severe liver insufficiency or renal insufficiency before randomization, aneurysm treatment requiring the use of other antiplatelet drugs after interventional therapy, receiving treatment with other investigational drugs or device trials currently will be excluded. Patients will be randomly assigned to the experimental group or control group at a 1:1 ratio. Experimental Group patients will receive cilostazol 100 mg twice daily for 14 consecutive days, in addition to the standard aSAH treatment. Control Group patients will receive a placebo twice daily (bid) for 14 consecutive days, in addition to the standard aSAH treatment. The primary study endpoint is incidence of delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH) within 14±2 days after randomization. Other secondary endpoints include neurological function prognosis at 90±7 days after randomization, incidence of intracranial rebleeding events within 90±7 days after randomization, incidence of other severe bleeding events within 90±7 days after randomization. This trial will provide important information for the development of clinical guidelines for reducing delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH).

Enrollment: 316 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• No rebleeding or new intracranial hemorrhage is shown on head CT within 6 hours after surgery.
• Understand and follow the procedures of clinical trial, participate voluntarily and sign the informed consent (the informed consent can be signed voluntarily by the person or guardian)

Exclusion criteria

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

• Modified Rankin Scale (mRS) score ≥ 3 before onset

• Patients with contraindications to cilostazol use:

  1. Allergy to cilostazol
  2. Severe heart failure（New York Heart Association (NYHA) Functional Classification Grade III or IV）
  3. Coagulation disorders or systemic bleeding (e.g., hemophilia, gastrointestinal bleeding, hemoptysis, etc.)
  4. Pregnant or lactating women

• Patients with severe organic diseases and an expected survival time of less than 90 days

• Severe liver insufficiency or renal insufficiency before randomization

• Aneurysm treatment requiring the use of other antiplatelet drugs after interventional therapy

• Currently receiving treatment with other investigational drugs or device trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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316 participants in 2 patient groups, including a placebo group

Cilostazol Group

Experimental group

Description:

Administer 100 mg cilostazol, twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.

Treatment:

Drug: Cilostazol 100 mg BID

Control Group

Placebo Comparator group

Description:

Implement placebo 100mg twice daily for 14 days and the standard aneurysmal subarachnoid treatment pathway.

Treatment:

Drug: placebo