Phase 3
Completed N=1,873
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
Source: ClinicalTrials.gov NCT00092677 ↗Enrolled (actual)
1,873
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) — 333; 355 Participants — p=0.591
Summary
The purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events) |
333; 355 | 0.591 |
| SECONDARY Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events) |
308; 326 | 0.732 |
| SECONDARY Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events) |
148; 187 | 0.024 sig |
| SECONDARY Change From Baseline in Peak Transaortic Jet Velocity |
0.613; 0.618 | 0.829 |
Eligibility Criteria
Inclusion Criteria
- Patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram.
Exclusion Criteria
- Patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.
Data sourced from ClinicalTrials.gov (NCT00092677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.