Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    6396
  • sponsor
    Beijing Tiantan Hospital
Updated on 30 July 2020
Investigator
Xia Meng, PhD
Primary Contact
Affiliated Hospital of Yangzhou University (0.4 mi away) Contact
+205 other location
aspirin
stroke
ticagrelor
clopidogrel
ischemia
ischemic stroke
cerebral infarction

Summary

The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.

Description

According to the Global Burden of Disease(GBD) Study 2016, China bears the greatest lifetime risk of stroke from 25-year-age onward. Minor ischemic events, including minor stroke and TIA, were major parts of stroke manifestations. Events (CHANCE) has shown that 21-day dual antiplatelet therapy (clopidogrel and aspirin) compared to aspirin alone which initiated within 24 hours after symptoms onset would reduce 32% risk of stroke recurrence within 90 day, but not in carriers of CYP2C19 loss-of-function (LOF) alleles. The primary purpose of this study is to compare ticagrelor plus aspirin with clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.

Both intent analysis (ITT) and compliance program set (PPS) were used for analysis.

We will use Kaplan-Meier estimates of the cumulative risk of stroke (ischemic or hemorrhagic) event during maximum 90-day follow-up, with hazards ratios and 95% CI calculated using Cox proportional hazards methods and the log-rank test to evaluate the treatment effect. All statistics will be 2-sided with P<0.05 considered significant, accounting for interim analyses.

All patients who received study drugs and with at least one safety follow-up record will be included in the safety population. The data for safety evaluation included adverse reactions observed during the trial and changes in laboratory data before and after treatment.

Details
Treatment clopidogrel and aspirin, Ticagrelor and Aspirin
Clinical Study IdentifierNCT04078737
SponsorBeijing Tiantan Hospital
Last Modified on30 July 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Cerebrovascular accident or Stroke or Transient Ischemic Attack?
Older than 40 Years
Acute onset of cerebral ischemia due to
Acute non-disabling ischemic stroke (NIHSS3 at the time of randomization)or
TIA with moderate-to-high risk of stroke recurrence (ABCD2 score 4 at the time of randomization)
Can be treated with study drug within 24 hours of symptoms onset(Symptom onset is defined by the "last see normal" principle)
CYP2C19 LOF alleles carriers
Informed consent signed

Exclusion Criteria

malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI
Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA
Preceding moderate or severe dependency (modified Rankin scale [mRS] score 3-5)
Contraindication to clopidogrel, ticagrelor or ASA ( Known allergy Severe renal or hepatic insufficiency Severe cardiac failure History of Hemostatic disorder or systemic bleeding History of thrombocytopenia or neutropenia History of drug-induced hematologic disorder or hepatic dysfunction
Hematokrit(HCT)<30%
Clear indication for anticoagulation(presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
History of intracranial hemorrhage or amyloid angiopathy
HIstory of aneurysm (intracranial aneurysm and peripheral aneurysm)
History of asthma or COPD (chronic obstructive pulmonary disease)
High-risk for bradyarrhythmia (first-degree or second-degree AV block caused by sinus node disease, and bradyarrhythmic syncope without pacemaker)
History of hyperuricemia nephropathy
Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs)
Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
Scheduled for surgery or interventional treatment requiring study drug cessation
Severe non-cardiovascular comorbidity with life expectancy < 3 months
Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
Dual antiplatelet treatment (or more than two antiplatelet agents) in 72 hours before randomization
Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization
Gastrointestinal bleed within 3 months or major surgery within 30 days
Diagnosis or suspicious diagnosis of acute coronary syndrome
Participation in another clinical study with an experimental product during the last 30 days
Currently receiving an experimental drug or device
Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet