Tiprogrel
DrugDay 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin.
NCT Number: NCT06601127
This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Phase 2
Central Hospital Affiliated to Shenyang Medical College, Shenyang, Liaoning, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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.
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.
Time frame: on the 90th day after treatment
Participants with ischemic stroke
Time frame: on the 21th day after treatment
Participants with ischemic stroke
Time frame: on the 21th and 90th day after treatment
Participants with serve composite ischemic events
Time frame: on the 21th and 90th day after treatment
Participants with nonfatal ischemic strokes
Time frame: on the 21th and 90th day after treatment
Participants with nonfatal myocardial infarction
Time frame: on the 21th and 90th day after treatment
Participants with death from ischemic vascular events
Time frame: on the 21th and 90th day after treatment
Participants with ischemic vascular events
Time frame: on the 21th and 90th day after treatment
Participants with stroke (ischemic or hemorrhagic)
Time frame: on the 21th and 90th day after treatment
Participants with cardiovascular death
Time frame: on the 90th day after treatment
Scores on the modified Rankin scale range"
Time frame: on the 21th and 90th day after treatment
Participants with severe bleeding (BARC3c and BARC 5)
Time frame: on the 21th and 90th day after treatment
Participants with mild bleeding (other than BARC3c and BARC 5)
Time frame: on the 21th and 90th day after treatment
Participants with major bleeding (ISTH criteria)
Time frame: on the 21th and 90th day after treatment
Participants with non-major bleeding (ISTH criteria)
Time frame: on the 21th and 90th day after treatment
Participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding
Time frame: on the 21th and 90th day after treatment
Participants with clinically relevant non-major bleeding (ISTH criteria) and minor bleeding (ISTH criteria)
Time frame: on the 21th and 90th day after treatment
Participants with all bleeding
Time frame: on the 21th and 90th day after treatment
Participants with hemorrhagic stroke
Time frame: on the 21th and 90th day after treatment
Participants with symptomatic intracranial hemorrhage
Time frame: on the 21th and 90th day after treatment
Participants with all-cause death
Time frame: on the 21th and 90th day after treatment
Participants with termination discontinuation due to bleeding
Time frame: on the 21th and 90th day after treatment
Participants with AE leading to discontinuation
Time frame: on the 21th and 90th day after treatment
Occurrence of AE and SAE
Time frame: on the 21th and 90th day after treatment
Changes in 12-lead electrocardiogram, vital signs, and laboratory tests
Time frame: on the 4th day after treatment
Participants with stroke progression (a ≥4 point increase on the NIHSS)
Contact information is provided by the study sponsor or research team.
Tianjin Institute of Pharmaceutical Research Co., Ltd
Other Gov
A Phase 2, Randomised, Double-blind, Positive-controlled, Multicentre Study of Tiprogrel in the Treatment of Patients with Acute Minor Ischaemic Stroke or High-risk Transient Ischaemic Attack.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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