Ischemic Stroke
Conditions
Brief summary
This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.
Detailed description
To evaluate the safety and efficacy of Tiprogrel at different doses within 24 hours after symptom onset in Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack. Patients wil be enrolled and randomized to Low-dose Tiprogrel, High-dose Tiprogrel and Clopidogrel group in a 1:1:1 ratio. Patients in Low-dose Tiprogrel group and High-dose Tiprogrel group will accept long term dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 90 days) . Patients in Clopidogrel group will accept dual antiplatelet therapy (DAPT) (Aspirin and Tiprogrel for 21 days followed by Clopidogrel on days 22 to 90) . The primary endpoint is Percent of participants with ischemic stroke on the 90th day after treatment.
Interventions
DRUGTiprogrel
Day 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
DRUGClopidogrel
Day 1, loading dose of Clopidogrel and loading dose of aspirin; Day 2-21, daily maintenance dose of Clopidogrel and daily maintenance dose of aspirin; D22-90: daily maintenance dose of Clopidogrel.
Sponsors
Tianjin Institute of Pharmaceutical Research Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 40 years 2. Acute Minor Ischaemic Stroke：AIS is defined as acute onset of neurological deficit attributed to focal brain ischaemia, NIHSS ≤5, and either of the following imaging characteristics: 1. Acute single infarction with ≥50% stenosis of a major intracranial or extracranial artery. 2. Acute multiple infarctions attributed to large-artery atherosclerosis, including non-stenotic vulnerable plaques. TIA with high risk of stroke: ABCD2 score ≥ 6 at the time of randomization, and the following imaging characteristic: a）TIA with ≥50% stenosis of a major intracranial or extracranial artery. 3）Can be treated with study drug within 24 hours of symptoms onset\*(\*Symptom onset is defined by the last seen normal principle) 4）A man or woman of childbearing potential does not have any plan to have a child from signing the informed consent to 3 months after the last dose 5）Written informed consent
Exclusion criteria
1. Bleeding or other pathological brain disorders including malformation, tumor, abscess or other major non-ischemic brain disease on baseline head CT or MRI 2. Isolated or pure sensory symptoms, isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI. 3. Preceding mRS\> 2 4. Contraindication to anti-platelet therapy 5. Clear indication for anticoagulation 6. Two or more antiplatelet drugs have been used continuously for ≥3 days before enrollment. 7. Used heparin or oral anticoagulant drugs within 10 days before enrollment 8. Undergone intravenous or arterial thrombolysis and mechanical thrombectomy within 24 hours before enrollment 9. History of intracranial hemorrhage or amyloid angiopathy 10. History of aneurysm 11. Diagnosis or suspicious diagnosis of acute coronary syndrome 12. History of asthma 13. High-risk for bradyarrhythmia 14. Anticipated requirement for long-term (\>5 days) non-steroidal anti-inflammatory drugs or NSAIDs within the 8th day of randomization 15. History of gastrointestinal bleeding within 3 months before enrollment or major surgery within 30 days 16. Iatrogenic causes of minor stroke or TIA 17. Planned or likely revascularization within the next 3 months, scheduled for surgery or interventional treatment requiring study drug cessation 18. Severe non-cardiovascular comorbidity with life expectancy \< 3 months 19. Women of childbearing age who have not taken effective contraceptive measures and have a positive pregnancy test record, as well as women who are pregnant or breastfeeding 20. Currently receiving an experimental drug or device 21. Participation in another clinical study with an experimental product during the last 30 days 22. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders 23. Hemoglobin \<90g/L % 24. Permanent hypertension 25. Subjects who were judged by the investigator to be unsuitable for this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants with ischemic stroke | on the 90th day after treatment | Participants with ischemic stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants with serve composite ischemic events: nonfatal ischemic strokes, nonfatal myocardial infarction or death from ischemic vascular causes | on the 21th and 90th day after treatment | Participants with serve composite ischemic events |
| Percent of participants with nonfatal ischemic strokes | on the 21th and 90th day after treatment | Participants with nonfatal ischemic strokes |
| Percent of participants with nonfatal myocardial infarction | on the 21th and 90th day after treatment | Participants with nonfatal myocardial infarction |
| Percent of participants with death from ischemic vascular events | on the 21th and 90th day after treatment | Participants with death from ischemic vascular events |
| Percent of participants with ischemic Stroke | on the 21th day after treatment | Participants with ischemic stroke |
| Percent of participants with stroke (ischemic or hemorrhagic) | on the 21th and 90th day after treatment | Participants with stroke (ischemic or hemorrhagic) |
| Percent of participants with cardiovascular death | on the 21th and 90th day after treatment | Participants with cardiovascular death |
| Scores on the modified Rankin scale range | on the 90th day after treatment | Scores on the modified Rankin scale range |
| Percent of participants with ischemic vascular events | on the 21th and 90th day after treatment | Participants with ischemic vascular events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants with termination discontinuation due to bleeding | on the 21th and 90th day after treatment | Participants with termination discontinuation due to bleeding |
| Percent of participants with AE leading to discontinuation | on the 21th and 90th day after treatment | Participants with AE leading to discontinuation |
| Percent of participants with severe bleeding (BARC3c and BARC 5) | on the 21th and 90th day after treatment | Participants with severe bleeding (BARC3c and BARC 5) |
| Changes in 12-lead electrocardiogram, vital signs, and laboratory tests | on the 21th and 90th day after treatment | Changes in 12-lead electrocardiogram, vital signs, and laboratory tests |
| Percent of participants with stroke progression (a ≥4 point increase on the NIHSS) | on the 4th day after treatment | Participants with stroke progression (a ≥4 point increase on the NIHSS) |
| Occurrence of AE and SAE | on the 21th and 90th day after treatment | Occurrence of AE and SAE |
| Percent of participants with mild bleeding (other than BARC3c and BARC 5) | on the 21th and 90th day after treatment | Participants with mild bleeding (other than BARC3c and BARC 5) |
| Percent of participants with major bleeding (ISTH criteria) | on the 21th and 90th day after treatment | Participants with major bleeding (ISTH criteria) |
| Percent of participants with non-major bleeding (ISTH criteria) | on the 21th and 90th day after treatment | Participants with non-major bleeding (ISTH criteria) |
| Percent of participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding | on the 21th and 90th day after treatment | Participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding |
| Percent of participants with clinically relevant non-major bleeding (ISTH criteria) and minor bleeding (ISTH criteria) | on the 21th and 90th day after treatment | Participants with clinically relevant non-major bleeding (ISTH criteria) and minor bleeding (ISTH criteria) |
| Percent of participants with all bleeding | on the 21th and 90th day after treatment | Participants with all bleeding |
| Percent of participants with hemorrhagic stroke | on the 21th and 90th day after treatment | Participants with hemorrhagic stroke |
| Percent of participants with symptomatic intracranial hemorrhage | on the 21th and 90th day after treatment | Participants with symptomatic intracranial hemorrhage |
| Percent of participants with all-cause death | on the 21th and 90th day after treatment | Participants with all-cause death |
Countries
China
Contacts
Primary ContactXiaofei Pan
Outcome results
None listed