Trial · NCT01994720
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite of Stroke/MI/Death | From randomization up to 97 days | Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). |
| Secondary | Number of Participants With Ischaemic Stroke | From randomization up to 97 days | Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). |
| Secondary | Net Clinical Outcome | From randomization up to 97 days | Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97). |
| Secondary | Number of Participants With Composite of Ischaemic Stroke, MI and CV Death | From randomization up to 97 days | Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). |
| Secondary | Number of Participants With All-Cause Death | From randomization up to 97 days | Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97). |
| Secondary | Number of Participants With CV Death | From randomization up to 97 days | Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). |
| Secondary | Number of Participants With MI | From randomization up to 97 days | Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) |
| Secondary | Number of Participants by Severity of Stroke and Overall Disability | From randomization up to 97 days | Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS. Modified Rankin Score: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. Disability defined as mRS \> 1. Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables. |
| Secondary | Number of Participants With Stroke | From randomization up to 97 days | Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97) |
| Secondary | Number of Participants With Fatal Stroke | From randomization up to 97 days | Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97). |
| Secondary | Number of Participants With Disabling Stroke | From randomization up to 97 days | Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). |
| Secondary | Change in NIHSS | From randomization up to 97 days | Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale): 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke. |
| Secondary | EQ-5D at Visit 1 (Enrolment) | Visit 1 (Enrolment) | EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
| Secondary | EQ-5D at Visit 2 (Day 7+-2d) | Visit 2 (Day 7+-2d) | EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
| Secondary | EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit | End of treatment visit (Day 90+-7d) | EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
| Secondary | EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit | Premature treatment discontinuation visit(<15 days after last dose) | EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
| Secondary | Number of Participants With PLATO Major Bleeding Event | From randomization up to 97 days | Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). PLATO Major bleeding is defined as a bleed that is any one of: * Fatal * Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages \<10 mm evident only on gradient-echo MRI) * Intrapericardial bleed with cardiac tamponade * Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery * Significantly disabling (eg. intraocular with permanent vision loss) * Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L) * Transfusion of 2 or more units (whole blood or packed red blood cells \[PRBCs\]) for bleeding. |
| Secondary | Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event | Time from first dose and up to and including 7 days following the date of last dose of the study | Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01994720/registered