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NCT03872401 (Evolocumab in Patients with cardiovascular risk): BVCT ex-ante prediction vs. reported outcome

On 31 Jul 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 2 Oct 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD.

Clinical Trial

NCTID
NCT03872401
Acronym
VESALIUS-CV
Drug Name
Evolocumab
Drug MoA
anti-PCSK9 inhibitor
Drug Modality
monoclonal antibody (mAb)
Drug Class
First-In-Class
Therapeutic Area
Cardiovascular Diseases
Indication
Patients with cardiovascular risk
Human Patients
12301
Sponsor
Amgen
Phase
Phase 3

Prediction of , index 2053

Prospective Prediction
Prediction Index
2053
Prediction Date
Commercial Prediction
partial SUCCESS (commercially sufficient yet moderate clinical benefit in MACE slightly superior to semaglutide yet moderately inferior to retatrutide)
Technical Prediction
SUCCESS (statistically significant clinical benefit in MACE compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
63 days in advance
Readout Data Interpretation
evolocumab + SoC met its primary endpoint in MACE reduction compared with SoC alone (detailed data undisclosed)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Phase
Phase 3
Status
Completed
Enrollment
12301
Lead sponsor
Amgen
Conditions
Coronary Heart Disease (CHD)
Interventions
DRUG: Evolocumab; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2019-06-11
Primary completion
2025-07-25
Completion
2025-07-25
Results first posted
2026-06-25
Primary outcomes
  • Number of Participants Who Experienced Coronary Heart Disease (CHD) Death, Myocardial Infarction (MI), or Ischemic Stroke, Whichever Occurred First (From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months)
  • Number of Participants Who Experienced CHD Death, MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization, Whichever Occurred First (From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months)

NCT03872401 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials