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

NCT06601127 | Recruiting Phase 2

• 1 other identifier: TY601A-P2-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Percent of participants with ischemic stroke

  Participants with ischemic stroke

  on the 90th day after treatment

Secondary Outcomes (9)

• Percent of 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

  on the 21th and 90th day after treatment

• Percent of participants with nonfatal ischemic strokes

  on the 21th and 90th day after treatment

• Percent of participants with nonfatal myocardial infarction

  on the 21th and 90th day after treatment

• Percent of participants with death from ischemic vascular events

  on the 21th and 90th day after treatment

Other Outcomes (15)

• Percent of 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)

  on the 21th and 90th day after treatment

• Percent of participants with major bleeding (ISTH criteria)

  on the 21th and 90th day after treatment

Study Arms (3)

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.

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.

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.

Drug: Clopidogrel

Interventions

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.

Low-dose Tiprogrel group

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.

Clopidogrel group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Institute of Pharmaceutical Research Co., Ltd: lead

Study Sites (2)

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, China

RECRUITING

Beijing Tiantan Hosptial, Capital Medical University

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Xiaofei Pan

CONTACT

+86-22-23006825; panxiaofei@tipr.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: February 21, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)