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Randomized Controlled Clinical Study of Clopidogrel with Indobufen or Aspirin in Ischemic Stroke or Transient Ischemic Attack

Randomized Controlled Clinical Study of Clopidogrel with Indobufen or Aspirin in Ischemic Stroke or Transient Ischemic Attack

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043087
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-02-09
Completion date
Unknown
Last updated
2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke/Transient Ischemic Attack

Interventions

Group 1:Clopidogrel with Indobufen
Group 2:Clopidogrel with Aspirin

Sponsors

The Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 or above. (2) First onset. (3) Patients with acute non-cardiac TIA or mild ischemic stroke (NIHSS score = 4) within 72 hours of onset, or patients with severe symptomatic intracranial artery stenosis (stenosis rate 70%-99%) within 1 month of onset. (4) The patient or his/her family signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Vascular malformation, tumor, abscess or other ischemic cerebrovascular diseases not caused by atherosclerosis. (2) Isolated sensory symptoms (such as numbness), isolated visual changes, or isolated dizziness or vertigo, but no evidence of acute infarction on baseline CT or MRI of the head. (3) A score of more than 2 on the modified Rankin scale prior to the occurrence of acute ischemic stroke or TIA. (4) There are clear indications of anticoagulant therapy (assumed cardiac source of emboli, such as atrial fibrillation or artificial heart valves). (5) History of intracranial hemorrhage; The anticipated demand for long-term non-investigational antiplatelet drugs or NSAIDs that affect platelet function. (6) Heparin therapy or oral anticoagulant therapy were given within the first 10 days of randomization. (7) gastrointestinal bleeding or major surgery within the first 3 months. (8) Planned or possible revascularization (any angioplasty or vascular surgery) within 3 months after screening (angiography should be performed prior to randomization if clinical indications are available). (9) Need to stop the study of drugs planned surgery or interventional therapy. (10) TIA or minor stroke caused by angiography or surgery. (11) Have a serious non-cardiovascular coexisting disease and a life expectancy of less than 3 months. (12) Women of child-bearing age who do not use reliable contraceptives, who have no documented negative pregnancy tests, and who receive other study drugs or devices. (13) Indobuprofen, aspirin and clopidogrel were contraindicated.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of stroke;Modified Rankin Scale;

Countries

China

Contacts

Public ContactLei Zhang

The Fifth Affiliated Hospital of Sun Yat-Sen University

zhangl92@sysu.edu.cn+86 13726209240

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026