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This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose Tiprogrel group | Experimental | Drug: Tiprogrel and Aspirin 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. |
|
| High-dose Tiprogrel group | Experimental | Drug: Tiprogrel and Aspirin 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. |
|
| Clopidogrel group | Active Comparator | Drug: Clopidogrel and Aspirin 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiprogrel | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with ischemic stroke | Participants with ischemic stroke | on the 90th day after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with ischemic Stroke | Participants with ischemic stroke | on the 21th day after treatment |
| Percent of participants with serve composite ischemic events: nonfatal ischemic strokes, nonfatal myocardial infarction or death from ischemic vascular causes |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants with severe bleeding (BARC3c and BARC 5) | Participants with severe bleeding (BARC3c and BARC 5) | on the 21th and 90th day after treatment |
| Percent of participants with mild bleeding (other than BARC3c and BARC 5) |
Inclusion Criteria:
Age ≥ 40 years
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofei Pan | Contact | +86-22-23006825 | panxiaofei@tipr.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital Affiliated to Shenyang Medical College | Recruiting | Shenyang | Liaoning | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Tiprogrel | Drug | Drug: Tiprogrel and Aspirin 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. |
|
| Clopidogrel | Drug | 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. |
|
Participants with serve composite ischemic events |
| on the 21th and 90th day after treatment |
| Percent of participants with nonfatal ischemic strokes | Participants with nonfatal ischemic strokes | on the 21th and 90th day after treatment |
| Percent of participants with nonfatal myocardial infarction | Participants with nonfatal myocardial infarction | on the 21th and 90th day after treatment |
| Percent of participants with death from ischemic vascular events | Participants with death from ischemic vascular events | on the 21th and 90th day after treatment |
| Percent of participants with ischemic vascular events | Participants with ischemic vascular events | on the 21th and 90th day after treatment |
| Percent of participants with stroke (ischemic or hemorrhagic) | Participants with stroke (ischemic or hemorrhagic) | on the 21th and 90th day after treatment |
| Percent of participants with cardiovascular death | Participants with cardiovascular death | on the 21th and 90th day after treatment |
| Scores on the modified Rankin scale range | Scores on the modified Rankin scale range" | on the 90th day after treatment |
Participants with mild bleeding (other than BARC3c and BARC 5)
| on the 21th and 90th day after treatment |
| Percent of participants with major bleeding (ISTH criteria) | Participants with major bleeding (ISTH criteria) | on the 21th and 90th day after treatment |
| Percent of participants with non-major bleeding (ISTH criteria) | Participants with non-major bleeding (ISTH criteria) | on the 21th and 90th day after treatment |
| Percent of participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding | Participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding | on the 21th and 90th day after treatment |
| Percent of participants with clinically relevant non-major bleeding (ISTH criteria) and minor bleeding (ISTH criteria) | Participants with clinically relevant non-major bleeding (ISTH criteria) and minor bleeding (ISTH criteria) | on the 21th and 90th day after treatment |
| Percent of participants with all bleeding | Participants with all bleeding | on the 21th and 90th day after treatment |
| Percent of participants with hemorrhagic stroke | Participants with hemorrhagic stroke | on the 21th and 90th day after treatment |
| Percent of participants with symptomatic intracranial hemorrhage | Participants with symptomatic intracranial hemorrhage | on the 21th and 90th day after treatment |
| Percent of participants with all-cause death | Participants with all-cause death | on the 21th and 90th day after treatment |
| Percent of participants with termination discontinuation due to bleeding | Participants with termination discontinuation due to bleeding | on the 21th and 90th day after treatment |
| Percent of participants with AE leading to discontinuation | Participants with AE leading to discontinuation | on the 21th and 90th day after treatment |
| Occurrence of AE and SAE | Occurrence of AE and SAE | on the 21th and 90th day after treatment |
| Changes in 12-lead electrocardiogram, vital signs, and laboratory tests | Changes in 12-lead electrocardiogram, vital signs, and laboratory tests | on the 21th and 90th day after treatment |
| Percent of participants with stroke progression (a ≥4 point increase on the NIHSS) | Participants with stroke progression (a ≥4 point increase on the NIHSS) | on the 4th day after treatment |
| Beijing Tiantan Hosptial, Capital Medical University | Not yet recruiting | Beijing | China |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |