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Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394950
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Brief Summary:

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunctional prognosis of thrombolytic patients has been a hot topic in the world.

Butyl phthalide is type I chemical drugs. Some multicenter randomized, double-blind, placebo-controlled clinical trials have showed that acute ischemic stroke patients taking butyl phthalide has better lateral branch circulation and living ability score than patients taking placebo. Besides, butyl phthalide treatment is safe. The animal experiment indicated that buphthalein could significantly improve secondary side branch circulation, recover the microarterial diameter of the soft meninges in the ischemic region and increase the blood flow rate.

Based on the discussion, we assume that: giving butyl phthalide to patients with acute ischemic stroke in advance, might promote and improve the formation of collateral circulation to freeze ischemia penumbra. Based on this hypothesis, we would like to explore the efficacy and safety of butyl phthalide combined with rtPA thrombolysis in the treatment of acute ischemic stroke.


Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Butyphthalide combined with rtPA Drug: rtPA Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke (BRAIS):a Pilot, Prospective, Random, and Double Blinded Multi-center Study
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: rtPA combined with Butyphthalide
Intravenous treatment with 25mg butyphthalide, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with 25mg butyphthalide 2 times/day for 14 days, followed by oral butyphthalide capsule (0.2g 3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines.
Drug: Butyphthalide combined with rtPA
Intravenous treatment with 25mg butyphthalide, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with 25mg butyphthalide 2 times/day for 14 days, followed by oral butyphthalide capsule (0.2g 3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines.

Active Comparator: rtPA compared with placebo
Intravenous treatment with placebo injection, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with placebo injection 2 times/day for 14 days, followed by oral placebo capsule (3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines.
Drug: rtPA
Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines




Primary Outcome Measures :
  1. Percentage of mRS score (0-2) (90 days) [ Time Frame: 90 days ]
    Percentage of mRS score (0-2) at 90 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years;
  2. Diagnosis of anterior circulation infarct;
  3. First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
  4. Time from onset to treatment ≤4.5 hours;
  5. SBP/DBP ≤ 180/110mmHg;
  6. No hemorrhagic imaging changes showed in CT;
  7. Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

  1. History of stroke within 3 months;
  2. History of intracranial hemorrhage;
  3. Suspected subarachnoid hemorrhage;
  4. Intracranial tumour, vascular malformation or arterial aneurysm;
  5. Major surgery within 1 month;
  6. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
  7. Platelet count < 100×109/L;
  8. Heparin therapy or oral anticoagulation therapy within 48 hours;
  9. Severe disease with a life expectancy of less than 3 months;
  10. Blood glucose < 50 mg/dL (2.7mmol/L);
  11. Patients who have received any other investigational drug or device within 3 months;
  12. Researchers consider patients inappropriate to participate in the registry. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394950


Contacts
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Contact: Xiao-wen Hou, Master 86 15840240196 sophia_hxw@163.com

Locations
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China
General Hospital of ShenYang Military Region Recruiting
ShenYang, China
Contact: Xin-Hong Wang, PhD    86-24-28897491    450341972@qq.com   
Sponsors and Collaborators
Hui-Sheng Chen
Investigators
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Study Director: chen huisheng, doctor General Hospital of Shenyang Military Region
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Responsible Party: Hui-Sheng Chen, Professor, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT03394950    
Other Study ID Numbers: k201731
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:
thrombolysis
Butyphthalide
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action