Ticagrelor Versus Cilostazol in Minor Ischemic Stroke or TIA

NCT06196047 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 23098816
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Along with the current clinical trial, the efficacy and safety of ticagrelor and aspirin administered within the first 24 hours of first-ever ischemic stroke compared to cilostazol and aspirin were assessed through NIHSS, mRS, and possible adverse effects.

Conditions

Ischemic Stroke

Keywords

ticagrelor; acute ischemic stroke; cilostazol; Egypt

Outcome Measures

Primary Outcomes (2)

• the rate of new stroke in each group

  Assessed during the follow-up period through telephone calls twice per week, a face-to-face interview, and suitable brain imaging in the outpatient clinic once per month and continued for three months

  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 (5)

• Value of National Institute of Health Stroke Scale (NIHSS) after one week

  7 days

• value of Modified Rankin Scale (mRS) at one week

  7 days

• 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

  90 days

Study Arms (2)

ticagrelor arm

ACTIVE COMPARATOR

the ticagrelor arm will receive (180 mg loading dose during the first 12 hours of stroke onset followed by 90 mg b.i.d from the 2nd to the 90th day) and aspirin at a loading dose of 75 to 300 mg, followed by 75 mg daily for 21 days.

Drug: Ticagrelor 90 MG

cilostazol arm

ACTIVE COMPARATOR

The cilostazol arm will receive (a 200mg loading dose during the first 12 hours of stroke onset, followed by 100mg twice daily from the 2nd day to the 90th day) and aspirin at a loading dose of 75 to 300 mg, followed by 75 mg daily for 21 days.

Drug: Cilostazol 100 MG

Interventions

Ticagrelor 90 MG DRUG

Efficacy and safety of 180 mg loading dose of ticagrelor administered within 24 hours of first-ever ischemic stroke followed by 90 mg bid for 3 months will be assessed through NIHSS, mRS, new ischemic stroke, and possible adverse effects.

Also known as: group A

ticagrelor arm

Cilostazol 100 MG DRUG

Efficacy and safety of 200 mg loading dose of cilostazol administered within 24 hours of first-ever ischemic stroke followed by 100 mg bid for 3 months will be assessed through NIHSS, mRS, new ischemic stroke, and possible adverse effects.

Also known as: group B

cilostazol arm

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 acute 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:

• We 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.
• For safety measures and to avoid associated confounders, we 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.
• We 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 considered pregnant and lactating patients or those with stroke due to venous thrombosis, those with wake-up stroke and stroke following cardiac arrest or profuse hypotension ineligible for our trial.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33155, Egypt

RECRUITING

Related Publications (5)

• Ortiz-Garcia J, Gomez CR, Schneck MJ, Biller J. Recent advances in the management of transient ischemic attacks. Fac Rev. 2022 Jul 22;11:19. doi: 10.12703/r/11-19. eCollection 2022.

  PMID: 35949262 BACKGROUND

• Toyoda K, Uchiyama S, Yamaguchi T, Easton JD, Kimura K, Hoshino H, Sakai N, Okada Y, Tanaka K, Origasa H, Naritomi H, Houkin K, Yamaguchi K, Isobe M, Minematsu K; CSPS.com Trial Investigators. Dual antiplatelet therapy using cilostazol for secondary prevention in patients with high-risk ischaemic stroke in Japan: a multicentre, open-label, randomised controlled trial. Lancet Neurol. 2019 Jun;18(6):539-548. doi: 10.1016/S1474-4422(19)30148-6.

  PMID: 31122494 RESULT

• Toyoda K, Uchiyama S, Hoshino H, Kimura K, Origasa H, Naritomi H, Minematsu K, Yamaguchi T; CSPS.com Study Investigators. Protocol for Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com): a randomized, open-label, parallel-group trial. Int J Stroke. 2015 Feb;10(2):253-8. doi: 10.1111/ijs.12420. Epub 2014 Dec 8.

  PMID: 25487817 RESULT

• Davis KA, Miyares MA, Dietrich E. Dual antiplatelet therapy with clopidogrel and aspirin after ischemic stroke: A review of the evidence. Am J Health Syst Pharm. 2015 Oct 1;72(19):1623-9. doi: 10.2146/ajhp140804.

  PMID: 26386103 RESULT

• Kheiri B, Osman M, Abdalla A, Haykal T, Swaid B, Ahmed S, Chahine A, Hassan M, Bachuwa G, Al Qasmi M, Bhatt DL. Clopidogrel and aspirin after ischemic stroke or transient ischemic attack: an updated systematic review and meta-analysis of randomized clinical trials. J Thromb Thrombolysis. 2019 Feb;47(2):233-247. doi: 10.1007/s11239-018-1786-z.

  PMID: 30511260 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ticagrelor; Cilostazol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Quinolines

Central Study Contacts

mohamed G Zeinhom, MD

CONTACT

2001009606828; mohamed_gomaa@med.kfs.edu.eg

sherihan R. ahmed, MD

CONTACT

2001113432342; sherihanrezk2016@gmail.com

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 either loading doses of ticagrelor and aspirin or cilostazol and aspirin by a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 900 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 900. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned on 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 ticagrelor and aspirin, and Drug B included cilostazol and aspirin. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: We will conduct our randomized controlled trial, which will contain 2 arms; the ticagrelor arm (group A) will receive (a 180 mg loading dose during the first 24 hours of stroke onset, followed by 90 mg b.i.d from the 2nd to the 90th day). The cilostazol arm will receive (a 200 mg loading dose during the first 24 hours of stroke onset, followed by 100mg twice daily from the 2nd day to the 90th day). All the patients in the two groups will receive aspirin at a loading dose of 75 to 300 mg, followed by 75 mg daily for 21 days.

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 9, 2024
• Study Start: December 1, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)