Ischemic StrokePhase 2NCT06601127
Study of Tiprogrel in the Treatment of High-risk Patients with Acute Ischemic Cerebrovascular Events (THRIVE).
A Phase 2 study testing Tiprogrel and Clopidogrel in people with Ischemic Stroke, run by Tianjin Institute of Pharmaceutical Research Co., Ltd at 2 sites in China.
Trial summary
This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tiprogrel and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 21 Feb 2025to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Acute single infarction with ≥50% stenosis of a major intracranial or extracranial artery.
- 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
Show all 31Show fewer
- Bleeding or other pathological brain disorders including malformation, tumor, abscess or other major non-ischemic brain disease on baseline head CT or MRI
- Isolated or pure sensory symptoms, isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
- Preceding mRS> 2
- Contraindication to anti-platelet therapy
- Clear indication for anticoagulation
- Two or more antiplatelet drugs have been used continuously for ≥3 days before enrollment.
- Used heparin or oral anticoagulant drugs within 10 days before enrollment
- Undergone intravenous or arterial thrombolysis and mechanical thrombectomy within 24 hours before enrollment
- History of intracranial hemorrhage or amyloid angiopathy
- History of aneurysm
- Diagnosis or suspicious diagnosis of acute coronary syndrome
- History of asthma
- High-risk for bradyarrhythmia
- Anticipated requirement for long-term (>5 days) non-steroidal anti-inflammatory drugs or NSAIDs within the 8th day of randomization
- History of gastrointestinal bleeding within 3 months before enrollment or major surgery within 30 days
- Iatrogenic causes of minor stroke or TIA
- Planned or likely revascularization within the next 3 months, scheduled for surgery or interventional treatment requiring study drug cessation
- Severe non-cardiovascular comorbidity with life expectancy < 3 months
- 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
- Currently receiving an experimental drug or device
- Participation in another clinical study with an experimental product during the last 30 days
- Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
- Hemoglobin <90g/L %
- Permanent hypertension
- Subjects who were judged by the investigator to be unsuitable for this clinical study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Tiantan Hosptial, Capital Medical University
Beijing
Yongjun Wang, yongjunwang@ncrcnd.org.cn
- Recruiting
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning
Runhui Li, lirh710717@163.com
About this study
Official title: 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.
This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Tiprogrel, Clopidogrel
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiprogrelDrug
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.
TiprogrelDrug
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.
ClopidogrelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tiprogrel |
| 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. Receives: Drug: Tiprogrel |
| 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. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants with ischemic stroke
Participants with ischemic stroke
Measured: on the 90th day after treatment
Secondary outcomes (9)
Percent of participants with ischemic Stroke
Participants with ischemic stroke
Measured: 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
Participants with serve composite ischemic events
Measured: on the 21th and 90th day after treatment
Percent of participants with nonfatal ischemic strokes
Participants with nonfatal ischemic strokes
Measured: on the 21th and 90th day after treatment
Percent of participants with nonfatal myocardial infarction
Participants with nonfatal myocardial infarction
Measured: on the 21th and 90th day after treatment
Percent of participants with death from ischemic vascular events
Participants with death from ischemic vascular events
Measured: on the 21th and 90th day after treatment
Percent of participants with ischemic vascular events
Participants with ischemic vascular events
Measured: on the 21th and 90th day after treatment
Percent of participants with stroke (ischemic or hemorrhagic)
Participants with stroke (ischemic or hemorrhagic)
Measured: on the 21th and 90th day after treatment
Percent of participants with cardiovascular death
Participants with cardiovascular death
Measured: on the 21th and 90th day after treatment
Scores on the modified Rankin scale range
Scores on the modified Rankin scale range"
Measured: on the 90th day after treatment
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 start21 Feb 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Institute of Pharmaceutical Research Co., Ltd
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601127
- Sponsor's protocol ID
- TY601A-P2-01
- Status last verified
- Mar 2025
- First submitted
- 2 Sep 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06601127
- Acronym / sponsor ID
- TY601A-P2-01
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tianjin Institute of Pharmaceutical Research Co., LtdOther government
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose Tiprogrel group | Experimental | Drug: TiprogrelDrug: 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: TiprogrelDrug: 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: ClopidogrelDrug: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
- Bleeding or other pathological brain disorders including malformation, tumor, abscess or other major non-ischemic brain disease on baseline head CT or MRI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TiprogrelDay 1, loading dose of tiprogrel and loading dose of aspirin; Day 2-90, daily maintenance dose of tiprogrel and daily maintenance dose of aspirin. | Drug | Low-dose Tiprogrel group |
| TiprogrelDrug: 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. | Drug | High-dose Tiprogrel group |
| ClopidogrelDay 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. | Drug | Clopidogrel group |
Primary outcome
Percent of participants with ischemic stroke
Time frame: on the 90th day after treatment
Participants with ischemic stroke
9 secondary outcomes
Percent of participants with ischemic Stroke
Time frame: 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
Time frame: on the 21th and 90th day after treatment
Percent of participants with nonfatal ischemic strokes
Time frame: on the 21th and 90th day after treatment
Percent of participants with nonfatal myocardial infarction
Time frame: on the 21th and 90th day after treatment
Percent of participants with death from ischemic vascular events
Time frame: on the 21th and 90th day after treatment
Percent of participants with ischemic vascular events
Time frame: on the 21th and 90th day after treatment
Percent of participants with stroke (ischemic or hemorrhagic)
Time frame: on the 21th and 90th day after treatment
Percent of participants with cardiovascular death
Time frame: on the 21th and 90th day after treatment
Scores on the modified Rankin scale range
Time frame: on the 90th day after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiprogrel and Clopidogrel in people with Ischemic Stroke, run by Tianjin Institute of Pharmaceutical Research Co., Ltd at 2 sites in China.
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 31 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofei Pan (+86-22-23006825, panxiaofei@tipr.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants with ischemic stroke (time frame: on the 90th day after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.