Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)

April 18, 2023 updated by: Ascension South East Michigan

Efficacy and Safety of Cilostazol-Nimodipine Combined Therapy on Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage (aSAH): A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial

The investigators seek to demonstrate that the combined use of cilostazol and nimodipine will significantly decrease the rate of delayed cerebral infarction and cerebral vasospasm after cerebrovascular intervention when compared to nimodipine alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This research study is for people who have a brain hemorrhage, due to a ruptured aneurysm. Adding the drug cilostazol to the standard care may improve outcomes after surgery. The blood within the brain following aneurysmal hemorrhage can have harmful effects on the blood vessels causing them to narrow and thus decrease blood flow; this process is called vasospasm. Decreased blood flow in the brain can lead to more damage. Delayed cerebral ischemia is a complication which is believed to be a consequence of reduced blood flow to the brain following this type of hemorrhage. Cilostazol opens blood vessels and reduces the formation of blood clots. The standard treatment of these hemorrhages currently involves the use of nimodipine which also relaxes blood vessels and allows blood to flow more freely. The combination of these two drugs cilostazol and nimodipine may improve neurologic outcomes after surgery.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older
  • Anterior circulation aneurysm
  • Patients who have undergone surgical intervention
  • Absence of rebleeding or new intracranial hemorrhage noted on post-intervention CT scan
  • Consent for study participation

Exclusion Criteria:

  • Non-aneurysmal subarachnoid hemorrhage
  • Multiple ruptured aneurysms
  • Patients with congestive heart failure
  • Severe aneurysmal subarachnoid hemorrhage (Hunt Hess Grade V)
  • Active pathological bleeding
  • Allergy to cilostazol
  • Positive pregnancy test
  • Coagulopathy not caused by anti-coagulant use
  • History of hemorrhagic complications (gastrointestinal bleeding, etc)
  • Uncontrolled or severe comorbidity that would qualify as an absolute contraindication for cilostazol
  • Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g. stent-assisted coiling or flow-diverting stent obliteration of aneurysm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway.
Other: Placebo
The standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
Experimental: Experimental
Administer 100 mg cilostazol, twice daily for 14 days. In addition, implement the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days, and the standard aneurysmal subarachnoid treatment pathway.
Drug: Cilostazol 100 MG
The addition of 100 mg cilostazol, twice daily for 14 days, to the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed Cerebral Infarction
Time Frame: Baseline
Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
Baseline
Delayed Cerebral Infarction
Time Frame: 1 week (+/- 2 days) postoperatively
Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
1 week (+/- 2 days) postoperatively
Delayed Cerebral Infarction
Time Frame: 1 month (+/- 7 days) postoperatively
Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
1 month (+/- 7 days) postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic Cerebral Vasospasm
Time Frame: At any point leading up to 14 days post-operation
Development of a new focal or global neurological deficit or deterioration of at least 2 points on the Glasgow Coma Scale which was not explained by initial hemorrhage, re-bleeding, hydrocephalus, surgical complications, fever, infections, or electrolyte or metabolic disturbances; regardless of cerebral infarctions or angiographic vasospasm on imaging
At any point leading up to 14 days post-operation
Radiographic Vasospasm
Time Frame: Between 7-10 days postoperatively
Arterial narrowing not attributable to atherosclerosis, catheter-induced vasospasm, or vessel hypoplasia
Between 7-10 days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Outcomes: Short-Form 12
Time Frame: Baseline, 1 month postoperatively, 3 month postoperatively, and 6 month postoperatively
Short-Form 12 is answered by the patient. On a scale of 0-100, a higher score means better overall physical and mental health.
Baseline, 1 month postoperatively, 3 month postoperatively, and 6 month postoperatively
Modified Rankin Scale
Time Frame: Baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively
The patient's clinical status is graded on a scale of 0-6. An increasing score means a worse functional outcome.
Baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension South East Michigan

Investigators

  • Principal Investigator: Boyd Richards, DO, Div of Neurosurgery Ascension Providence Hospital MSU College of Human Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be made available following publication upon request at the discretion of the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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