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NCT Number: NCT06601127

Study of Tiprogrel in the Treatment of High-risk Patients with Acute Ischemic Cerebrovascular Events (THRIVE).

This study is designed to evaluate efficacy and safety of tiprogrel in the treatment of patients with acute ischemic cerebrovascular events.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central Hospital Affiliated to Shenyang Medical College, Shenyang, Liaoning, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percent of participants with ischemic stroke

    Time frame: on the 90th day after treatment

    Participants with ischemic stroke

Secondary outcomes

  1. Percent of participants with ischemic Stroke

    Time frame: on the 21th day after treatment

    Participants with ischemic stroke

  2. 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

    Participants with serve composite ischemic events

  3. Percent of participants with nonfatal ischemic strokes

    Time frame: on the 21th and 90th day after treatment

    Participants with nonfatal ischemic strokes

  4. Percent of participants with nonfatal myocardial infarction

    Time frame: on the 21th and 90th day after treatment

    Participants with nonfatal myocardial infarction

  5. Percent of participants with death from ischemic vascular events

    Time frame: on the 21th and 90th day after treatment

    Participants with death from ischemic vascular events

  6. Percent of participants with ischemic vascular events

    Time frame: on the 21th and 90th day after treatment

    Participants with ischemic vascular events

  7. Percent of participants with stroke (ischemic or hemorrhagic)

    Time frame: on the 21th and 90th day after treatment

    Participants with stroke (ischemic or hemorrhagic)

  8. Percent of participants with cardiovascular death

    Time frame: on the 21th and 90th day after treatment

    Participants with cardiovascular death

  9. Scores on the modified Rankin scale range

    Time frame: on the 90th day after treatment

    Scores on the modified Rankin scale range"

Other outcomes

  1. Percent of participants with severe bleeding (BARC3c and BARC 5)

    Time frame: on the 21th and 90th day after treatment

    Participants with severe bleeding (BARC3c and BARC 5)

  2. Percent of participants with mild bleeding (other than BARC3c and BARC 5)

    Time frame: on the 21th and 90th day after treatment

    Participants with mild bleeding (other than BARC3c and BARC 5)

  3. Percent of participants with major bleeding (ISTH criteria)

    Time frame: on the 21th and 90th day after treatment

    Participants with major bleeding (ISTH criteria)

  4. Percent of participants with non-major bleeding (ISTH criteria)

    Time frame: on the 21th and 90th day after treatment

    Participants with non-major bleeding (ISTH criteria)

  5. Percent of participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding

    Time frame: on the 21th and 90th day after treatment

    Participants with BARC 1, BARC 2, BARC3a, BARC 3b bleeding

  6. Percent of 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 clinically relevant non-major bleeding (ISTH criteria) and minor bleeding (ISTH criteria)

  7. Percent of participants with all bleeding

    Time frame: on the 21th and 90th day after treatment

    Participants with all bleeding

  8. Percent of participants with hemorrhagic stroke

    Time frame: on the 21th and 90th day after treatment

    Participants with hemorrhagic stroke

  9. Percent of participants with symptomatic intracranial hemorrhage

    Time frame: on the 21th and 90th day after treatment

    Participants with symptomatic intracranial hemorrhage

  10. Percent of participants with all-cause death

    Time frame: on the 21th and 90th day after treatment

    Participants with all-cause death

  11. Percent of participants with termination discontinuation due to bleeding

    Time frame: on the 21th and 90th day after treatment

    Participants with termination discontinuation due to bleeding

  12. Percent of participants with AE leading to discontinuation

    Time frame: on the 21th and 90th day after treatment

    Participants with AE leading to discontinuation

  13. Occurrence of AE and SAE

    Time frame: on the 21th and 90th day after treatment

    Occurrence of AE and SAE

  14. Changes in 12-lead electrocardiogram, vital signs, and laboratory tests

    Time frame: on the 21th and 90th day after treatment

    Changes in 12-lead electrocardiogram, vital signs, and laboratory tests

  15. Percent of participants with stroke progression (a ≥4 point increase on the NIHSS)

    Time frame: on the 4th day after treatment

    Participants with stroke progression (a ≥4 point increase on the NIHSS)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaofei Pan

CONTACT

[email protected]

+86-22-23006825

Sponsors and collaborators

Lead sponsor

Tianjin Institute of Pharmaceutical Research Co., Ltd

Other Gov

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Mar 7, 2025

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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