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Phosphodiesterase Inhibitor

Cilostazol + Nimodipine for Subarachnoid Hemorrhage

Phase 4

Recruiting

Led By Boyd Richards, DO

Research Sponsored by Ascension South East Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have undergone surgical intervention

Anterior circulation aneurysm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively

Awards & highlights

Study Summary

This trial will compare the effects of two drugs on stroke patients.

Who is the study for?

This trial is for adults who've had surgery to treat a brain aneurysm that bled into the space around their brain. They must not have rebleeding, be allergic to cilostazol, pregnant, or have bleeding disorders unrelated to medication use. People with severe other illnesses or needing blood thinners after surgery can't join.Check my eligibility

What is being tested?

The study tests if taking cilostazol along with nimodipine reduces complications like delayed brain damage and vessel spasms more effectively than just nimodipine alone after treatment for a ruptured brain aneurysm.See study design

What are the potential side effects?

Cilostazol may cause headaches, diarrhea, abnormal stools, palpitations (feeling your heart beat), dizziness, and rash. Nimodipine has similar side effects including low blood pressure, slow heart rate, and gastrointestinal upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery for my condition.

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I have a brain aneurysm in the front part of my brain.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Delayed Cerebral Infarction

Secondary outcome measures

Radiographic Vasospasm

Cerebral Vasospasm

Other outcome measures

Modified Rankin Scale

Quality of Life Outcomes: Short-Form 12

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ascension South East MichiganLead Sponsor

18 Previous Clinical Trials

33,070 Total Patients Enrolled

Boyd Richards, DOPrincipal InvestigatorDiv of Neurosurgery Ascension Providence Hospital MSU College of Human Medicine

Media Library

Cilostazol (Phosphodiesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04148105 — Phase 4

Brain Aneurysm Research Study Groups: Placebo, Experimental

Brain Aneurysm Clinical Trial 2023: Cilostazol Highlights & Side Effects. Trial Name: NCT04148105 — Phase 4

Cilostazol (Phosphodiesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04148105 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the official regulatory status of Cilostazol 100 MG?

"There is ample evidence of Cilostazol 100 MG's safety, so it was awarded a rating of 3."

Answered by AI

Is this trial currently enrolling participants?

"Affirmative. The details on clinicaltrials.gov demonstrate that the study is presently seeking volunteers, having been first posted on November 1st 2019 and most recently updated October 27th 2022. It requires 120 individuals to be recruited from one medical centre."

Answered by AI

How many participants are currently involved in this clinical investigation?

"Affirmative. The clinical trial is still open and available to the public according to information on clinicaltrials.gov; it was first posted in November of 2019 and has been recently modified as of October 2022. This research seeks 120 participants from 1 site location."

Answered by AI

Is the age range of participants greater than two decades?

"This medical trial has set the minimum age of enrollment at 18 and the upper limit is 100 years old."

Answered by AI

Does my profile fit the criteria for participation in this scientific experiment?

"In order to qualify for this trial, applicants must suffer from hemorrhage and be aged between 18-100. The quota of 120 patients is currently available."

Answered by AI

Has Cilostazol 100 MG been studied extensively before?

"At this moment, 5 clinical trials are in progress for Cilostazol 100 MG with none of them being conducted at the third stage. Shibīn Al Kawm, Menoufia is one area where these experiments are taking place while there are a total of five locations running studies on Cilostazol 100 MG."

Answered by AI