Skip to content

Randomized controlled clinical study: Cilostazol with Indobufen and aspirin with clopidogrel in Ischemic Stroke or Transient Ischemic Attack

Randomized controlled clinical study: Cilostazol with Indobufen and aspirin with clopidogrel in Ischemic Stroke or Transient Ischemic Attack

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044112
Enrollment
Unknown
Registered
2021-03-11
Start date
2021-03-05
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

Ischemic Stroke or Transient Ischemic Attack

Interventions

Group 1:cilostazol with Indobufen
Group 2:aspirin with clopidogrel

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 years or above. (2) First onset. (3) Patients with acute non-cardiac TIA or mild ischemic stroke with a high risk of stroke recurrence (ABCD2 score >= 4) within 72 hours of onset (NIHSS score <= 3); Or ischemic stroke or TIA patients with severe 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, cilotazole, aspirin and clopidogrel were contraband.

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 4, 2026