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Clinical study of Jiening aspirin enteric coated sustained release tablets

Clinical study of Jiening aspirin enteric coated sustained release tablets

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040550
Enrollment
Unknown
Registered
2020-12-02
Start date
2018-06-21
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Mild stroke / TIA

Interventions

Experimental group:50 mg asprin Intestinal sustained release tablets
control:100 mg asprin intestinal release tablets

Sponsors

Anzhen Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Among the non cardiogenic mild stroke / TIA patients diagnosed by clinical and neuroimaging in recent 90 days, ABCD2 score of TIA patients >=4 points, and NIHSS score of mild stroke patients =45 years old; 5) Patients understand the trial process and the risk of participating in the trial voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with aspirin allergy or contraindication, and clear bleeding risk, such as erosive gastritis, peptic ulcer, or history of gastrointestinal and intracranial hemorrhage; 2) Patients with previous intravascular stent implantation (including coronary artery, extracranial and extracranial vessels, peripheral artery, etc.); 3) Patients who need to be combined with other antiplatelet or anticoagulant therapy for various reasons, such as after stent implantation, atrial fibrillation, venous thrombosis of lower extremity, coronary artery stenosis > 50, extracranial and extracranial vascular stenosis > 75%, etc; 4) Those who can not continue to use antiplatelet drugs for 12 months: if they need elective surgery in the near future; 5) According to Canadian Society of cardiovascular disease classification standard, angina pectoris grade II or above; 6) Patients with other serious heart, kidney, liver diseases, hematological diseases, malignant tumors and bleeding tendency; 7) Participants in clinical trials of other drugs in recent 3 months; 8) Taking other non steroidal anti-inflammatory drugs or hormones; 9) The platelet count was beyond the normal range; 10) The researcher decided that it was not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
stroke or/and TIA recurrence;

Secondary

MeasureTime frame
Major negative cardiac events (MACE): including angina pectoris, myocardial infarction, acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG);All cause death;

Contacts

Public ContactBi Qi

Anzhen Hospital Affiliated to Capital Medical University

461420053@qq.com+86 15169082156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026