Trial · NCT05963568
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite vascular risk factor control | 12 and 24 months | Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP \<140 mm Hg, LDL-cholesterol \<100mg/dl, antiplatelet adherence by pill count \>90%) at month 12 and month 24 (sustainment of effect) |
| Secondary | Major adverse cardiovascular events (MACE) | 24 months | MACE to be assessed include recurrent stroke: fatal/severely disabling stroke or non-fatal stroke; coronary artery disease: acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudication committee by reviewing available clinical notes supported by investigations for example CT scans, EKGs, troponin tests, death certificates or verbal autopsy if death occurs outside hospital. |
| Secondary | Change in adherence to medical therapy | Month 3, 6, 9, 12, 18 & 24 | |
| Secondary | Safety and tolerability | Up to 24 months | Side effects, adverse events, treatment withdrawal |
| Secondary | Health-related quality of life EuroQol-5D | Up to 24 months | EuroQol-5D questionnaire (0-100 with 100 being the best) |
| Secondary | Health-related quality of life Neuro-QoLTM | Up to 24 months | NINDS Neuro-QoLTM (Quality of Life in Neurological Disorders) questionnaires (8-40 with 40 being the best) |
| Other | Organizational Capacity for Change Score | Up to 30 months | Adoption i.e. Organizational Capacity for Change (OCC Scale Score comparison) with stratification by level of healthcare delivery. The measure is a 32-item multidimensional scale that evaluates an organization's capacity to upgrade or revise existing organizational competencies, while cultivating new competencies that enable the organization to survive and prosper. It comprises different aspects of leadership, employee behavior, and an organizational infrastructure supporting organizational change. Items are rated on a 5-point Likert scale. OCC has a Cronbach α of 0.87. |
| Other | Mean Cost of Implementation | Up to 30 months | Implementation Cost (mean monthly health expenses compared to standard of care) |
| Other | Proportion who achieves systolic blood pressure <140 mmHg | Months 12 and 24 | |
| Other | Proportion who achieves blood pressure <140/90 mmHg | Months 12 and 24 | |
| Other | Proportion who achieves blood pressure < 130 / 80 mmHg | Months 12 and 24 | |
| Other | Proportion who achieves LDL-cholesterol <100 mg/dl | Months 12 and 24 | |
| Other | Proportion who achieves LDL-cholesterol <70 mg/dl | Months 12 and 24 | |
| Other | Proportion who achieves antiplatelet adherence of at least >=80% | Months 12 and 24 | |
| Other | Proportion who achieves antiplatelet adherence of at least >= 90% | Months 12 and 24 | |
| Other | Comparison of absolute and mean changes from baseline for blood pressure | Up to 24 months | systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, measures of visit-to-visit variability in blood pressure |
| Other | Comparison of absolute and mean changes from baseline for lipids | Up to 24 months | Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride |
| Other | Proportion with recurrent strokes (fatal or non-fatal) | Up to 24 months | |
| Other | Proportion with coronary artery disease | Up to 24 months | |
| Other | Proportion with heart failure | Up to 24 months |
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/NCT05963568/registered