Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA

NCT ID: NCT06591351

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 870 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-10-10

Brief Summary

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

Detailed Description

The investigators conducted a single-blinded randomized controlled trial after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it.

The investigators got written informed consent from all eligible patients or their first order of kin before randomization.

The study will be composed of 2 arms clopidogrel arm, which consisted of 435 patients who received a 300 mg loading dose followed by 75 mg once daily from the 2nd to the 90th day), and the cilostazol arm, consisting of 435 patients who received (a 200 mg loading dose during the first 24 hours of stroke onset followed by 100 mg twice daily from the 2nd day to the 90th day), both groups received 300 mg loading aspirin and 75 mg daily dose of aspirin.

Study Procedures:

Every patient in our study will undergo:

clinical workup: History, clinical assessment & NIHSS were recorded on admission, day 7, and the Modified Rankin Scale as a follow-up after one week and 3 months.

Detection of Risk Factors & Profiles:

Echocardiography TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients.

4- ESR & Lipid Profile& liver functions: All will be tested routinely for all patients.

Imaging Follow-UP Non-contrast CT brain on admission Day 2 MRI: after 2 days of admission, all the patients in this study will have a brain MRI (stroke protocol; T1W, T2W, FLAIR, DWI, T2 Echo Gradient, MRA of all intra-cerebral vessels).

CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT.

Primary End Point:

The primary efficacy outcome was the rate of new stroke at 90 days, and the primary safety outcome was the rate of drug hemorrhagic complications using the PLATO bleeding definition.

• Secondary End Point: The secondary efficacy outcomes were to evaluate the rates of patients who achieved a significant reduction in NIHSS (decrease of four points or more) at the seventh day or discharge compared to baseline, the rates of a favorable outcome with (mRS = 0-2) after one week and after 90 days in a face-to-face interview in the outpatient clinic, rates of a composite of recurrent stroke, myocardial infarction and death due to vascular events after 90 days of follow-up, while the secondary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cilostazol and aspirin

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.

Group Type: ACTIVE_COMPARATOR

Cilostazol 100 MG

Intervention Type: 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,

clopidogrel and aspirin

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

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: 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,

Interventions

Cilostazol 100 MG

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,

Intervention Type: DRUG

Clopidogrel

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,

Intervention Type: DRUG

Other Intervention Names

group A; group B

Eligibility Criteria

Inclusion Criteria

• the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with large-vessel 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed G. zeinhom, MD

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed G. Zeinhom, MD

Role: PRINCIPAL_INVESTIGATOR

neurology department kafr el-sheikh university

Locations

Kafr Elsheikh University Hospital

Kafr ash Shaykh, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mohamed G. Zeinhom, MD

Role: CONTACT

mohamed_gomaa@med.kfs.edu.eg

2001009606828

sherihan R. ahmed, MD

Role: CONTACT

sherihan_rezq@med.kfs.edu.eg

2001113432342

Facility Contacts

mohamed G. Zeinhom, MD

Role: primary

mohamed_gomaa@med.kfs.edu.eg

2001009606828

sherihan R. ahmed, MD

Role: backup

sherihan_rezq@med.kfs.edu.eg

2001007481842

References

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.

Reference Type: RESULT

PMID: 18190818 (View on PubMed)

Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003 Jul;23(6):441-50. doi: 10.1046/j.1468-2982.2003.00546.x.

Reference Type: RESULT

PMID: 12807523 (View on PubMed)

Other Identifiers

230988167145914

Identifier Type: -

Identifier Source: org_study_id