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Trial · NCT07908082

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRecruitment rate defined as the number of participants randomized per center-month.Through study completion, an average of 18 monthsNumber of participants randomized per center-month, counting each center from the date it is activated and able to enroll participants until completion of recruitment.
SecondaryStudy treatment initiation, assessed as the proportion of randomized participants who initiate study treatment.Up to month 3 following randomization
SecondaryTime to study treatment initiation, assessed as the number of days from randomization to first study treatment administration among randomized participants who initiate treatment.Up to 30 days following randomization
SecondaryTreatment adherence, assessed using the proportion of days covered.Up to 12 months following randomizationThe proportion of days covered is calculated as the number of days covered by the dispensed study medication divided by the total number of days in the treatment period, multiplied by 100.
SecondaryParticipant retention, defined as the proportion of randomized participants completing the 12-month follow-up visit.Up to 12 months following randomization
SecondaryCompleteness of follow-up data, assessed as the proportion of randomized participants completing the 12-month visit for whom all clinical outcome data required for the definitive trial are available.Up to 12 months following randomization
SecondaryStudy-drug delivery performance, assessed as the proportion of participants experiencing ≥1 delivery-related delay resulting in delayed treatment initiation or treatment interruption.Up to 12 months following randomization
SecondaryBarriers for recruitment, assessed by the frequency of reasons for ineligibility.Through study completion, an average of 18 months
SecondaryBarriers for adherence, assessed by the frequency of reasons for treatment discontinuation.Through study completion, an average of 18 months
SecondaryBarriers for retention, assessed by the frequency of reasons for withdrawal from the trial.Through study completion, an average of 18 months
OtherTime to first ischemic event (in days)Up to 12 months following randomization
The efficacy composite outcome of the full trial will be the time to first ischemic event, defined as the first occurence of ischemic death, new ischemic vision loss, ischemic stroke, transient ischemic attack, myocardial infarction, unstable angina requiring hospitalization, or acute limb ischemia requiring intervention.
OtherTime to first major bleeding event (in days)Up to 12 months following randomizationMajor bleeding is defined according to the Bleeding Academic Research Consortium criteria.

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.

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