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Trial · NCT07341958

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryPercentage change in Lp(a) from baseline at 90 days.From baseline to 90 days after randomization
SecondaryIncidence of new stroke (including hemorrhagic and ischemic stroke) within 90 days.From baseline to 90 days after randomization
Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke
SecondaryIncidence of composite clinical endpoint events within 90 daysFrom baseline to 90 days after randomizationIncluding recurrent ischemic stroke, myocardial infarction, rehospitalization for unstable angina or heart failure, and cardiovascular death
SecondaryIncidence of myocardial infarction within 90 days.From baseline to 90 days after randomizationAcute myocardial infarction is diagnosed by the third edition of the international general diagnostic criteria (Glob Heart. 2012 Dec;7(4):275-95)
SecondaryIncidence of vascular death within 90 days.From baseline to 90 days after randomization
Vascular death includes stroke, sudden cardiac death, acute myocardial infarction, heart failure, pulmonary embolism, heart / cerebrovascular intervention or surgery (death unrelated to acute MI) and other cardiovascular causes of death \[such as: Arrhythmia irrelevant with sudden cardiac death, aortic aneurysm rupture, or peripheral artery disease. Any death of unknown/unclear cause that occurs within 30 days after stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery will be regarded as death due to stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery, respectively.
SecondaryIncidence of all-cause death within 90 days.From baseline to 90 days after randomization
SecondaryProportion of patients with poor functional outcome (mRS score 2-6) at 90 days.From baseline to 90 days after randomizationThe Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. The modified Rankin Scale (mRS)= 2-6: poor functional outcome
SecondaryProportion of patients with Lp(a) <30 mg/dL at 90 daysFrom baseline to 90 days after randomization
SecondaryPercent reduction in ApoB and LDL-C levels from baseline to 90 daysFrom baseline to 90 days after randomization
SecondaryLDL-C goal attainment rate (<1.8 mmol/L or reduction ≥ 50%) at 90 daysFrom baseline to 90 days after randomization
SecondaryModerate and severe bleeding events (GUSTO classification)From baseline to 90 days after randomization
The GUSTO classification provides a three-tiered (severe, moderate, mild), criteria-driven framework for consistently reporting bleeding complications in clinical research, with a focus on hemodynamic impact and objective laboratory/transfusion data.
SecondaryHepatotoxicity: Post-treatment ALT or AST levels exceeding 3 times the upper limit of normal upon re-measurementFrom baseline to 90 days after randomization
Hepatotoxicity in this context is defined as a confirmed elevation of liver enzymes after treatment. Specifically, it means that a follow-up blood test shows either ALT or AST levels to be more than three times higher than the normal limit. This is a standard safety criterion for detecting potential drug-induced liver injury in clinical trials.
SecondaryMuscle toxicityFrom baseline to 90 days after randomizationPost-treatment creatine kinase levels exceeding 10 times the upper limit of normal upon re-measurement, or occurrence of skeletal muscle adverse events (myalgia, myopathy, or rhabdomyolysis)
SecondaryUpper Respiratory Tract Infection (URTI):From baseline to 90 days after randomizationCommon infections affecting the nose, sinuses, throat, or larynx (e.g., common cold, sinusitis). These are general illnesses, not necessarily treatment-related.
SecondaryUrinary Tract Infection (UTI)From baseline to 90 days after randomizationAn infection in any part of the urinary system (bladder, urethra, kidneys). It is monitored as a common potential infection during trials.
SecondaryInjection Site Reactions:From baseline to 90 days after randomizationIncluding papules, bleeding, discoloration, pain, itching, rash, induration, erythema, swelling, etc., at the injection site
SecondaryAllergic Reactions:From baseline to 90 days after randomizationUndesirable immune system responses to the treatment, ranging from mild (rash, itching) to severe, life-threatening anaphylaxis.
SecondaryOther Adverse Events/Serious Adverse Events (AEs/SAEs):From baseline to 90 days after randomizationOther Adverse Events/Serious Adverse Events (AEs/SAEs):

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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