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

NCT02975076 | Unknown

• 1 other identifier: XH-16-037
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke, Acute; Ischemic Attack, Transient

Keywords

Sanchitongshu; Acute Minor Stroke; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with the180-day new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)

  180 days

Secondary Outcomes (10)

• Percentage of patients with the 180-day new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually

  180 days

• Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 180 days follow-up

  180 days

• Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 180 days follow-up)

  180 days

• Further efficacy exploratory analysis:Impairment (changes in Barthel Index at 180 days follow-up)

  180 days

• Further efficacy exploratory analysis: stroke impact scale

  180 days

Study Arms (2)

Sanchitongshu & placebo of lopidogrel

EXPERIMENTAL

sanchitongshu 1 capsule each time ,three times a day and Aspirin 75mg for 90 days ; placebo of clopidogrel 75mg daily for 21 days after randomization

Drug: Sanchitongshu; Drug: Aspirin; Drug: placebo of clopidogrel

placebo of Sanchitongshu & lopidogrel

PLACEBO COMPARATOR

placebo of sanchitongshu1 capsule each time ,three times a day and Aspirin 75mg for 90 days;clopidogrel 75mg per day for 21 days after randomization

Drug: placebo of Sanchitongshu; Drug: Aspirin; Drug: Clopidogrel

Interventions

Sanchitongshu DRUG

The study drugs were manufactured according to Good Manufacturing Practice (GMP) by the Pharmaceutical Factory of Chengdu Huasun Group Inc. Ltd. and presented in the form capsules. Every Sanchitongshu capsule weighed 200 mg, contained 100 mg of panaxatriol saponin (PTS) and 100 mg inactive excipient (starch). PTS comprised of dried extracts from roots of Radix Notoginseng, and had been standardised with respect to Ginsenoside Rg1 (50%), Ginsenoside Re (6%), Notoginsenoside R1 (11%). The amounts of the active ingredients were determined by analytical RP-HPLC using an acetonitrile-water gradient system as mobile hase. The peaks were detected by UV-DAD.

Also known as: Radix/Rhizoma Notoginseng extract

Sanchitongshu & placebo of lopidogrel

placebo of Sanchitongshu DRUG

The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch).

placebo of Sanchitongshu & lopidogrel

Aspirin DRUG

Also known as: Aspirin Enteric-coated Tablets

Sanchitongshu & placebo of lopidogrel; placebo of Sanchitongshu & lopidogrel

Clopidogrel DRUG

Also known as: Clopidogrel Bisulfate

placebo of Sanchitongshu & lopidogrel

placebo of clopidogrel DRUG

Sanchitongshu & placebo of lopidogrel

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age of 40 years to 80 years
• 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.
• Patients had ability to accept the medicine and rules of the research.
• Patients had no serious complications and had normal renal function and liver function.

You may not qualify if:

• age younger than 40 and older than 80
• Patients need thrombolysis
• hemorrhage; other conditions, such as vascular malformation, tumor, abcess, or other major nonischemic brain disease
• 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
• 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
• TIA or minor stroke caused by angiography or surgery
• a clear indication for anticoagulation therapy(presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardio valve)
• anticipated requirement for long-term nonstudy antiplatelet drugs or for non steroidal antiinflammatory drugs affecting platelet function
• accompanied with severe disorders of heart, liver, and kidney
• severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months.
• history of hemorrhage or bleeding tendency of other system( such as thrombocytopenic purpura)
• gastrointestinal bleeding or major surgery within the previous 3 months
• planned or probable revascularization(any angioplasty or vascular surgery)within 3 months after.Operation or Interventional Therapy require discontinuation of study drug
• Aspirin, clopidogrel or notoginseng allergy
• a history of alcoholism or drug abuse in past 12 months

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xinhua Hospital

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Xiaorong Wang, Master

CONTACT

13621712767; wangxr_mail@163.com

Fei Lu

CONTACT

021-25076146; xinhuakeyan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share