Sanchitongtshu Plus Asprine for Minor Ischemic Stroke or Transient Ischemic Attack: A Randomized Double-blind Study

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Agents of sanchi have been widely used as a complementary medicine for stroke in China. Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger anti-platelet activity than other agents of sanchi. The investigators's aim was to investigate the synergistic action of aspirin combined with sanchitongshu capsule in the treatment of patients with minor ischemic stroke and transient ischemic attack.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

1. age of 40 years to 80 years

2. diagnosis of an acute minor ischemic stroke or transient ischemic attack; and ability to start the study drug within 24 hours after symptom onset, which was defined as the point at which the patient reported no longer being in a normal condition. Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale(NIHSS). TIA was defined as focal brain ischemia with resolution of symptoms within 24 hours after onset plus a moderate-to-high risk of stroke recurrence(defined as a score≥4 at the time of randomization on the ABCD2). All patients were confirmed by brain CT or MRI.

3. Patients had ability to accept the medicine and rules of the research.

4. Patients had no serious complications and had normal renal function and liver function.

Exclusion Criteria:

1. age younger than 40 and older than 80

2. Patients need thrombolysis

3. hemorrhage; other conditions, such as vascular malformation, tumor, abcess, or other major nonischemic brain disease

4. isolated sensory symptoms(e.g., numbness), isolated visual changes, or isolated dizziness or vertigo without evidence of acute infarction on baseline CT or MRI of the head

5. a score of more than 2 on the modified Rankin scale(scores ranges from 0(no symptoms) to 6(death))immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline

6. TIA or minor stroke caused by angiography or surgery

7. a clear indication for anticoagulation therapy(presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardio valve)

8. anticipated requirement for long-term nonstudy antiplatelet drugs or for non steroidal antiinflammatory drugs affecting platelet function

9. accompanied with severe disorders of heart, liver, and kidney

10. severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months.

11. history of hemorrhage or bleeding tendency of other system( such as thrombocytopenic purpura)

12. gastrointestinal bleeding or major surgery within the previous 3 months

13. planned or probable revascularization(any angioplasty or vascular surgery)within 3 months after.Operation or Interventional Therapy require discontinuation of study drug

14. Aspirin, clopidogrel or notoginseng allergy

15. a history of alcoholism or drug abuse in past 12 months

16. pregnant and lactating women, or women of childbearing age without taking any effective contraceptive measures

17. patients have other serious disease or abnormal laboratory results that is unfavorable to join the research

18. patients receiving other investigational drugs or devices

19. incomprehension of the character and category of the research and unable to follow the research plan