Status:
UNKNOWN
Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
Lead Sponsor:
Xijing Hospital
Conditions:
Ischemic Stroke
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
Using placebo as control, The purpose of this study is to evaluate the efficacy and safety of methanesulfonic acid cinepazide injection to relieve disabled degree of acute cerebral infarction patients...
Detailed Description
The study will enroll 288 acute cerebral infarction patients. Patients will be assigned randomly to receive either Methanesulfonic acid cinepazide injection or placebo treatment. All patient in the st...
Eligibility Criteria
Inclusion
- Age between 40 and 75 years old，male/ female；
- The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score \<2 before this disease）
- Patients is proved by head skull CT and cerebral hemorrhage was excluded；
- course of disease≤72h，the NIHSS score is ≥7 and ≤22；
- Patients who voluntarily sign written informed consent. -
Exclusion
- Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
- Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
- Patients who suffer from severe complications, and expected survival period is within three months.
- Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
- Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
- Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
- Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
- Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal（ALT,AST≥1.5 times of upper normal limit，Cr\>upper normal limit）.
- Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
- Patients who have complications of mental illness un can not or do not want willing to cooperate .
- Doubt or does have alcohol, drug abuse history
- Allergic constitution or allergic to the test drug ingredients .
- Pregnancy and lactation women or those who has a recent fertility plan
- Patients who have participated in other clinical experiments three months before this test.
- The patients who is unsuitable to participate in the clinical test in the view of researchers
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01851759
Start Date
October 1 2013
End Date
August 1 2014
Last Update
May 10 2013
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032