Trial · NCT02618577
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of Stroke, Systemic Embolism, or Cardiovascular Death | 28 months | Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure. |
| Secondary | Components of the Primary Outcome, Stroke | 28 months | Time from randomisation to the first occurrence of ischemic stroke; incidence of first occurence of outcome measure. |
| Secondary | Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS) | 28 months | PCI, CABG |
| Secondary | All-cause Death | 28 months | All-cause death |
| Secondary | Major Bleeding Events | 28 months | according to the International Society on Thrombosis and Haemostasis (ISTH) definitions |
| Secondary | Quality of Life Changes at 12 and 24 Months Compared to Baseline | Baseline, 12 months and 24 months. | Adjusted mean change from baseline at 12 and 24 months of Quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L): The resulting score of the UK index ranges from 1 (for the best state) to - 0.285 (for the worst state), with 5.1% of the states valued as worse than dead. EQ5D- VAS: visual-analogue scale (0 worst to 100 best). Subscales of the UK index score were combined by adding up EQ-5D-5L index values with STATA using the English (ENG) Devlin value set, Version 1.1 (Updated 01/12/2020). Karnofsky Performance Scale is an 11-point scale from 0 to 100 (0 worst to 100 best). |
| Secondary | Patient Satisfaction at 12 and 24 Months Compared to Baseline | Baseline, 12 months and 24 months. | Adjusted change from baseline at 12 and 24 months measured by the Perception of Anticoagulant Treatment Questionnaire: For convenience score, a 0 - 100 scale; for satisfaction score a 0 - 100 scale; for both scores, the higher the score, the higher the convenience/satisfaction. |
| Secondary | Cost Effectiveness and Health Resource Utilisation | 28 months | estimated by quantification of relevant events, interventions, nights spent in hospital and cardiovascular therapies |
| Secondary | Autonomy Status | Baseline and 24 months | Autonomy status only in patients with stroke during study participation, assessed at 24 month by modified Rankin scale. (Score ranges from 1 to 8, a higher score indicates a higher grade of disability) |
| Secondary | Components of the Primary Outcome, Systemic Embolism | 28 months | Time from randomisation to the first occurrence of systemic embolism; incidence of first occurence of outcome measure. |
| Secondary | Components of the Primary Outcome, Cardiovascular Death | 28 months | Time from randomisation to the first occurrence of cardiovascular death; incidence of first occurence of outcome measure. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02618577/registered