Combining Aspirin With Cilostazol or Clopidogrel in Minor Stroke or TIA

NCT06591299 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 23098816714
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 1

Brief Summary

Along with the current clinical trial, the efficacy and safety of a 300 mg loading dose of clopidogrel administered within 24 hours of the first-ever minor stroke or TIA compared to 200 mg cilostazol were assessed through NIHSS, mRS, and possible adverse effects

Conditions

Ischemic Stroke

Keywords

cilostazol; clopidogrel; minor stroke; Egypt

Outcome Measures

Primary Outcomes (2)

• rate of new stroke

  Rates of new stroke occur within three months of treatment. The investigators will perform follow-ups of the patient during visits to the outpatient clinic, and brain CT and/ or MRI will be done if there is suspicion of a new stroke.

  90 days

• Rate of drug-related hemorrhagic complications

  the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin \> 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites.

  90 days

Secondary Outcomes (3)

• value of Modified Rankin Scale(mRS) at three months

  3 months

• rate of composite recurrent stroke, myocardial infarction, and death due to vascular events

  3 months

• rate of drug adverse effects

  3 months

Study Arms (2)

cilostazol and aspirin

ACTIVE COMPARATOR

The cilostazol arm will receive (a 200 mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 100 mg twice daily from the 2nd day to the 90th day) and an open-label loading 300 mg aspirin, followed by a maintenance dose of 75 mg aspirin.

Drug: Cilostazol 100 MG

clopidogrel and aspirin

ACTIVE COMPARATOR

The clopidogrel arm will receive (a 300 mg loading dose of clopidogrel during the first 24 hours of stroke onset, followed by 75 mg once daily from the 2nd day to the 90th day) and open-label loading 300 mg aspirin, followed by a maintenance dose of 75 mg aspirin.

Drug: Clopidogrel 75mg

Interventions

Cilostazol 100 MG DRUG

Efficacy and safety of 200 mg cilostazol followed by 100 mg twice daily for three months and loading 300 mg aspirin and 75 mg aspirin maintenance will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects,

Also known as: group A

cilostazol and aspirin

Clopidogrel 75mg DRUG

Efficacy and safety of 300 mg clopidogrel followed by 75mg once daily for three months and loading 300 mg aspirin and 75 mg aspirin maintenance will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects,

Also known as: group B

clopidogrel and aspirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with minor ischemic stroke or TIA who received antiplatelet treatment within the first 24 hours of the onset of ischemic stroke. Patients are not eligible for rt-PA treatment

You may not qualify if:

• The investigators excluded patients who had not been followed up on for 90 days after enrollment, those with NIHSS \< 5 or who had rapidly resolving symptoms before imaging results, and patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).
• The investigators excluded patients who had clinical seizures at the onset of their stroke, as well as those who had symptoms of any major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks, and those who were on warfarin, regular ticagrelor during the week before admission, or chemotherapy within the previous year.
• The investigators excluded patients with active peptic ulcers, GIT surgery, bleeding history within the last year, and those with a history of major surgery within the last three months.
• The investigators ruled out of our trial patients who had a known allergy to the study drugs and those with INR \> 1.4 or P.T. \>18 or blood glucose level \< 50 or \> 400 mg/DL or blood pressure \< 90/60 or \> 185/110 mmHg on admission or Platelets \< 100,000.
• The investigators excluded pregnant and lactating patients and those with stroke due to venous thrombosis and stroke following cardiac arrest or profuse hypotension ineligible for our trial.
• Patients with contraindications to the study drugs were excluded.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

RECRUITING

Related Publications (2)

• Paciaroni M, Ince B, Hu B, Jeng JS, Kutluk K, Liu L, Lou M, Parfenov V, Wong KSL, Zamani B, Paek D, Min Han J, Del Aguila M, Girotra S. Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-Analysis. Cardiovasc Ther. 2019 Dec 1;2019:1607181. doi: 10.1155/2019/1607181. eCollection 2019.

  PMID: 31867054 RESULT

• Meyer DM, Albright KC, Allison TA, Grotta JC. LOAD: a pilot study of the safety of loading of aspirin and clopidogrel in acute ischemic stroke and transient ischemic attack. J Stroke Cerebrovasc Dis. 2008 Jan-Feb;17(1):26-9. doi: 10.1016/j.jstrokecerebrovasdis.2007.09.006.

  PMID: 18190818 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Cilostazol; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines

Study Officials

• mohamed G. Zeinhom, MD

  neurology department kafr el-sheikh university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed G. Zeinhom, MD

CONTACT

2001009606828; mohamed_gomaa@med.kfs.edu.eg

sherihan R. ahmed, MD

CONTACT

2001113432342; sherihan_rezq@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent statistician generated a blocked randomization sequence using computer-generated random numbers; in a one-to-one ratio, participants were randomly assigned to receive loading doses of clopidogrel and aspirin or cilostazol and aspirin by a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 870 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 870. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrollment numbers starting from 1, which were mentioned in their files. Files with the same number as the patient enrolment number were opened, and the patients were assigned to receive drugs A or B. Drug A included clopidogrel, and Drug B included cilostazol. Both groups received an open-label loading dose of 300 mg of aspirin and continued on aspirin 75 mg daily.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: The investigators will conduct our single-blinded randomized controlled trial, which will contain two arms; the clopidogrel arm will receive (a 300 mg loading dose during the first 24 hours of stroke onset, followed by 75 mg daily from the 2nd to the 90th day). The cilostazol arm will receive (a 200mg loading dose during the first 24 hours of stroke onset, followed by 100 mg twice daily from the 2nd to the 90th day). both groups received open-labelloading dose 300 mg aspirin and continued on open-label aspirin 75 mg daily

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: April 15, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)