Ischemic StrokePhase 3NCT06591312
Combining Aspirin With Ticagrelor or Clopidogrel in Minor Stroke or TIA
A Phase 3 study testing Ticagrelor 90 MG and Clopidogrel in people with Ischemic Stroke, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Along with the current clinical trial, the efficacy and safety of a 180 mg loading dose of ticagrelor administered within 24 hours of the first-ever minor stroke or TIA compared to 300 mg clopidogrel were assessed through NIHSS, mRS, and possible adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Ticagrelor 90 MG and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 25 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafr Elsheikh University Hospital
Kafr ash Shaykh, 33511
mohamed G. Zeinhom, MD, 2001009606828, mohamed_gomaa@med.kfs.edu.eg
sherihan R. ahmed, MD, 2001007481842, sherihan_rezq@med.kfs.edu.eg
About this study
Official title: Combining Aspirin With Ticagrelor or Clopidogrel in Minor Stroke or TIA, a Randomized Controlled Trial
Along with the current clinical trial, the efficacy and safety of a 180 mg loading dose of ticagrelor administered within 24 hours of the first-ever minor stroke or TIA compared to 300 mg clopidogrel were assessed through NIHSS, mRS, and possible adverse effects.
Read the 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 ticagrelor arm, which consisted of 450 patients who received a 180mg loading dose followed by 90 mg twice daily from the 2nd to the 90th day), and the clopidogrel arm, consisting of 450 patients who received (a 300mg loading dose during the first 24 hours of stroke onset followed by 75mg once daily from the 2nd day to the 90th day),
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 two 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
- Being tested
- Ticagrelor 90 MG, Clopidogrel
- Keywords
- ticagrelor, clopidogrel, minor stroke, Egypt
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90 MGDrug
Also called group A
The ticagrelor arm will receive (a 180mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 90mg once 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.
ClopidogrelDrug
Also called group B
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.
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor and aspirin arm | Active comparator | The ticagrelor arm will receive (a 180 mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 90 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. Receives: Drug: Ticagrelor 90 MG |
| clopidogrel and aspirin arm | Active comparator | The clopidogrel arm will receive (a 300 mg loading dose of cilostazol 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. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Secondary outcomes (3)
value of Modified Rankin Scale(mRS) at three months
rmRS Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability; its value ranges from 0 to 6; the lower the score, the better the stroke outcome. A favorable stroke outcome is considered with mRS value equal to two or less.
Measured: 3 months
rate of composite recurrent stroke, myocardial infarction, and death due to vascular events
Rates of new stroke, TIA, myocardial infarction, or death from vascular events within three months of treatment, the investigators will perform follow-ups of the patient during visits to the outpatient clinic and perform needed investigations such as brain imaging, Electrocardiography, arterial and venous duplex ultrasound imaging.
Measured: 3 months
rate of drug adverse effects
all side effects related to the medications of our study will be reported
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2022
- Primary completion10 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 ticagrelor arm will receive (a 180 mg loading dose during the first 24 hours of stroke onset, followed by 90 mg twice daily from the 2nd to the 90th day). Both groups received an open-label loading dose of 300 mg aspirin and continued on open-label aspirin 75 mg daily
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed G. zeinhom, MD, Kafrelsheikh University
- Investigators
- mohamed G. Zeinhom, MD, Principal investigator, neurology department kafr el-sheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591312
- Sponsor's protocol ID
- 230988167145
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All the data that support the findings of this research will be available from the corresponding author M. Zeinhom upon reasonable request.
Publications
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.
PubMed 18190818Gachet C, Stierle A, Cazenave JP, Ohlmann P, Lanza F, Bouloux C, Maffrand JP. The thienopyridine PCR 4099 selectively inhibits ADP-induced platelet aggregation and fibrinogen binding without modifying the membrane glycoprotein IIb-IIIa complex in rat and in man. Biochem Pharmacol. 1990 Jul 15;40(2):229-38. doi: 10.1016/0006-2952(90)90683-c.
PubMed 2375765
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Aspirin With Ticagrelor or Clopidogrel in Minor Stroke or TIA, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06591312
- Acronym / sponsor ID
- 230988167145
- Conditions
- Ischemic Stroke
- Keywords
- ticagrelor, clopidogrel, minor stroke, Egypt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Along with the current clinical trial, the efficacy and safety of a 180 mg loading dose of ticagrelor administered within 24 hours of the first-ever minor stroke or TIA compared to 300 mg clopidogrel 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 ticagrelor arm, which consisted of 450 patients who received a 180mg loading dose followed by 90 mg twice daily from the 2nd to the 90th day), and the clopidogrel arm, consisting of 450 patients who received (a 300mg loading dose during the first 24 hours of stroke onset followed by 75mg once daily from the 2nd day to the 90th day),
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 two 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 ticagrelor arm will receive (a 180 mg loading dose during the first 24 hours of stroke onset, followed by 90 mg twice daily from the 2nd to the 90th day). Both groups received an open-label loading dose of 300 mg aspirin and continued on open-label aspirin 75 mg daily
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor and aspirin arm | Active comparator | Drug: Ticagrelor 90 MGThe ticagrelor arm will receive (a 180 mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 90 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. |
| clopidogrel and aspirin arm | Active comparator | Drug: ClopidogrelThe clopidogrel arm will receive (a 300 mg loading dose of cilostazol 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor 90 MGAlso: group AThe ticagrelor arm will receive (a 180mg loading dose of cilostazol during the first 24 hours of stroke onset, followed by 90mg once 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 | Ticagrelor and aspirin arm |
| ClopidogrelAlso: group BThe 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 and aspirin arm |
Primary outcome
rate of new stroke
Time frame: 90 days
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.
Rate of drug-related hemorrhagic complications
Time frame: 90 days
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.
3 secondary outcomes
value of Modified Rankin Scale(mRS) at three months
Time frame: 3 months
rate of composite recurrent stroke, myocardial infarction, and death due to vascular events
Time frame: 3 months
rate of drug adverse effects
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 18190818Meyer 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.
- Results publication: PubMed 2375765Gachet C, Stierle A, Cazenave JP, Ohlmann P, Lanza F, Bouloux C, Maffrand JP. The thienopyridine PCR 4099 selectively inhibits ADP-induced platelet aggregation and fibrinogen binding without modifying the membrane glycoprotein IIb-IIIa complex in rat and in man. Biochem Pharmacol. 1990 Jul 15;40(2):229-38. doi: 10.1016/0006-2952(90)90683-c.
- Individual participant dataSharing planned: No. All the data that support the findings of this research will be available from the corresponding author M. Zeinhom upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed G. Zeinhom, MD principal investigator
neurology department kafr el-sheikh university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor 90 MG and Clopidogrel in people with Ischemic Stroke, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed G. Zeinhom, MD (2001009606828, mohamed_gomaa@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of new stroke (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591312, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.