Trial · NCT05963568
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
NCT05963568, Phase 3, Recruiting, Northern California Institute of Research and Education
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II). Trials, record NCT05963568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05963568
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
- NCT number
- NCT05963568
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 1,000 participants, estimated
- Lead sponsor
- Northern California Institute of Research and Education
- Conditions
- Stroke, Medication Adherence
- Interventions
- Polycap
- First posted
- 2023-07-27
- Last updated
- 2026-07-06
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41727852 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05963568
GET https://conductscience.org/api/trials/v1/NCT05963568/registered?page=2