Trial · NCT06322953
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH. | 12 weeks | The total number of patients that have a haemorrhagic or thrombotic event within 12 weeks following tICrH. |
| Secondary | Time to first haemorrhagic or thrombotic event. | 12 weeks | Time to first haemorrhagic or thrombotic event. |
| Secondary | Time to first haemorrhagic event | 12 weeks | Time to first haemorrhagic event |
| Secondary | Time to first thrombotic event | 12 weeks | Time to first thrombotic event |
| Secondary | Time to death | 12 and 26 weeks | Time to death |
| Secondary | Functional outcome measured using modified Rankin Scale (mRS) | 26 weeks | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6 with 0 being no symptoms and 6 being dead. |
| Secondary | Functional outcome measured using Barthel Index | 26 weeks | The barthel index is a tool to rank the patient's independence in 10 areas of daily living, such as feeding, bathing, dressing, and mobility. The total score ranges from 0-100 with 0 having no independence and 100 being totally independent. |
| Secondary | Functional outcome measured using extended Glasgow Outcome Scale (GOS-E) | 26 weeks | The scale runs from 0-6, running from perfect health without symptoms to death. The Extended Glasgow Coma Scale (EGCS) expands upon the traditional GCS by adding additional components to provide a more comprehensive assessment of a patient's neurological status. It consists of 8 levels with 1 being dead and 8 meaning patient has made a complete recovery. |
| Secondary | Functional outcome measured using Rockwood Frailty Score | 26 weeks | The Rockwood Clinical Frailty Scale is a tool used to assess a patient's overall level of frailty based on their physical fitness, comorbidities, and ability to perform daily activities. It classifies patients into 9 categories, ranging from 1 (very fit) to 9 (terminally ill), with higher scores indicating greater frailty and vulnerability to adverse health outcomes. |
| Secondary | Overall Quality of Life measured by EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire | 12 and 26 weeks | The EuroQol 5 Dimensions 5 Levels (EQ5D5L) is a standardized instrument used for measuring generic health status and health-related quality of life. This system comprises five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, ranging from no problems to extreme problems. In addition to the descriptive system, the EQ5D5L includes a vertical visual analogue scale (VAS) where respondents rate their current health on a scale from 0 to 100, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. |
| Secondary | Patient/caregiver attitudes to (re)starting DOAC following tICrH | Within 60 days of study approach | This qualitative sub-study will explore patient and caregiver attitudes to recommencing a DOAC following tICrH. An individual semi-structured interview, lasting 30-60 minutes with a qualitative researcher will be undertaken to elicit their perceptions and beliefs about DOACs, in relation to stroke prevention and risks of recurrent ICrH. The interview will be conducted in person/remotely (depending on participant preference) within 60 days of the study approach. |
| Secondary | Healthcare resource use | 12 and 26 weeks | A client service receipt inventory questionnaire (CSRI) will be administered to participants to collect information regarding healthcare services used. The CSRI will collect detailed data on visits to general practitioners, specialists, hospital admissions, outpatient appointments, and mental health services. Services accessed such as home care, day care, residential care, and support services for individuals with disabilities or mental health needs. Information about prescription medications and over-the-counter drugs taken. informal care provided by family members or friends, as well as other forms of support such as transportation services or assistance with daily living activities. The data collected through the CSRI will be used to quantify the costs associated with different types of services and interventions, assess the impact of services on outcomes such as quality of life or functioning, and inform decision-making in healthcare and social care policy. |
| Secondary | Incremental cost per quality-adjusted life year (QALY) gained | 12 and 26 weeks |
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/NCT06322953/registered