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Trial · NCT05687448

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryMajor Adverse Clinical Events (MACE)Up to 3.5 months
The primary endpoint is a composite efficacy endpoint including death from any cause, myocardial infarction, stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism and valve thrombosis.
SecondaryBleedingUp to 3.5 monthsISTH major and non-major clinically relevant bleeding
SecondaryDeathUp to 3.5 monthsIncluding cardiovascular and non cardiovascular death
SecondaryMyocardial infarctionUp to 3.5 months
SecondaryStrokeUp to 3.5 months
SecondarySystemic embolismUp to 3.5 months
SecondaryDeep vein thrombosis or pulmonary embolismUp to 3.5 months
SecondaryValve thrombosisUp to 3.5 months
SecondaryBleedingUp to 3.5 monthsAccording to ISTH major and non-major clinically relevant bleeding, BARC and TIMI 6, BARC and TIMI Classifications
SecondaryEchographic parameter of aortic valveUp to 3.5 monthsVariation of mean aortic gradient (mm/Hg)
SecondaryAssessment of coagulationUp to 3.5 monthsMeasured by thrombin generation in a subgroup population (n=216)
SecondaryTo evaluate platelet activation (sP-selectin) in a subgroup population (n = 216)Up to 3.5 months
SecondaryTo build a population PK/PD in the experimental groupUp to 3.5 monthsMeasuring the apixaban concentration (anti-Xa activity expressed in ng/mL) (apixaban, n = 108)

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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