Cardioembolic Stroke
Conditions
Interventions
Experimental group:Antiplatelet therapy + Qidan Tongmai Tablet, 4 tablets each time, three times daily, for twelve weeks.
Control group :Antiplatelet therapy + Qidan Tongmai Tablet placebo, 4 tablets each time, three times daily, for twelve weeks.
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for cardioembolic stroke. (2) Meets the diagnostic criteria for atrial fibrillation. (3) Meet the diagnostic criteria for Qi deficiency syndrome and blood stasis syndrome. (4) Time from the onset of the current stroke to enrollment is = 30 days. (5) Age between 18 and 85 years (inclusive). (6) A HAS-BLED score (a bleeding risk assessment for atrial fibrillation) of = 3. (7) Demonstrates good compliance and is able to cooperate with the information collection, complete the course of medication, and adhere to the follow-up schedule throughout the study. (8) The subject has provided informed consent and has voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Unstable vital signs, or presence of abnormal liver or kidney function (AST = 2 times the upper limit of normal or ALT = 2 times the upper limit of normal or Cr = 1.5 times the upper limit of normal), or presence of other life-threatening severe diseases with an expected survival of = 12 months; (2) Complicated with intracranial hemorrhage or other non-ischemic encephalopathy, aneurysm, etc.; (3) Atrial fibrillation caused by reversible conditions such as hyperthyroidism, recent surgery, pericarditis, etc.; (4) Already completed or planning to undergo left atrial appendage occlusion or radiofrequency ablation during the study period; (5) Complicated with moderate or severe mitral stenosis or other valvular heart diseases, post-mechanical/bioprosthetic valve replacement, post-cardiac valve repair, etc.; (6) Women who are planning pregnancy, pregnant, or breastfeeding; (7) Currently using or requiring anticoagulant therapy in the near future; (8) Allergic to the components of Qidan Tongmai Tablet or its placebo; (9) Concurrent participation in other drug clinical trials or participation in other drug clinical trials within 1 month before enrollment; (10) Other conditions deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major adverse cardiovascular and cerebrovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| major adverse cardiovascular and cerebrovascular events;Stroke Syndrome Elements Rating Scale Score;Short Form-36 Health Survey (SF-36);Percentage of mRS Score = 1 point;The percentage of subjects with Barthel index score = 75; | — |
Countries
China
Contacts
Public ContactLi Zhou
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed