Trial · NCT03635749
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stroke | 90 days | Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke |
| Secondary | Composite vascular events | 90 days | stroke (including hemorrhagic and ischemic stroke), myocardial infarction, and cardiovascular death. |
| Secondary | Ischemic stroke | 90 days | An acute focal infarction of the brain or retina. Criteria:(1) acute onset of a new focal neurological deficit with clinical or imaging evidence of infarction lasting more than 24 hours and not attributable to a non-ischemic etiology (not associated with brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease); or (2) acute onset of a new focal neurological deficit and not attributable to a non-ischemic etiology lasting less than 24 hours, but accompanied by neuroimaging evidence of new brain infarction; or, (3) rapid worsening of an existing focal neurological deficit (an increase in NIHSS of ≥4 on the basis of a primary ischemic stroke, excluding hemorrhagic transformation or symptomatic cranial disease after infarction) lasting more than 24 hours and not attributable to a non-ischemic etiology, and accompanied by new ischemic changes on brain MRI or CT. |
| Secondary | Transient ischemic attack | 90 days | A neurological deficit of sudden onset, resolving completely, attributed to focal brain or retinal ischemia without evidence of associated acute focal infarction of the brain. Criteria: rapid onset of a focal neurological deficit that is without evidence of acute focal infarction of the brain, and is not attributable to a non-ischemic etiology (brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease) |
| Secondary | Myocardial infarction | 90 days | Acute myocardial infarction is diagnosed by the third edition of the international general diagnostic criteria (Glob Heart. 2012 Dec;7(4):275-95) |
| Secondary | Vascular death | 90 days | Vascular death includes stroke, sudden cardiac death, acute myocardial infarction, heart failure, pulmonary embolism, heart / cerebrovascular intervention or surgery (death unrelated to acute MI) and other cardiovascular causes of death \[such as: Arrhythmia irrelevant with sudden cardiac death, aortic aneurysm rupture, or peripheral artery disease. Any death of unknown/unclear cause that occurs within 30 days after stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery will be regarded as death due to stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery, respectively. |
| Secondary | All-cause death | 90 days | All-cause death |
| Secondary | Poor functional outcome | 90 days | The modified Rankin Scale (mRS)= 2-6 |
| Secondary | Quality of life (EQ-5D scale) | 90 days | EQ-5D scale index score ≤0.5 |
| Secondary | Change of atherosclerotic plaque using high-resolution magnetic resonance imaging (HR-MRI) | 90 days | Change of atherosclerotic plaque using high-resolution magnetic resonance 。 Patients in HR-MRI subgroup only |
| Secondary | Early Neurological Deficits | 7 days | NIHSS score increase of no less than 2points |
| Secondary | Ordinal stroke or TIA | 90 days | The new stroke or TIA is classified on a six-level ordered category scale combined vascular events with mRS score at 90 days or at 1year, respectively: fatal stroke (stroke with subsequent death), severe stroke (stroke followed by mRS of 4-5), moderate stroke (stroke followed by mRS of 2-3), mild stroke (stroke followed by mRS of 0-1), TIA and no stroke/TIA. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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