A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

For Condition: Cardiovascular Diseases

ID: NCT01492361

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken

Diet & Lifestyle / Therapy Care

Expected Availability Horizon

Coming Soon (1–3 yrs away)

StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.

EligibleThis study is looking exclusively for patients diagnosed with the condition.

Primary Outcome Measures

Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. — Time Frame: Total follow-up time of up to approximately 6 years.
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.

View Secondary Outcome Measures (9)

Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke. — Time Frame: Total follow-up time of up to approximately 6 years.
The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Composite of CV Death or Nonfatal MI (Including Silent MI). — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.
Fatal or Nonfatal MI (Including Silent MI). — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications. — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.
CV Death. — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with an occurrence of CV death during the follow-up period.
Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization. — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Fatal or Nonfatal Stroke. — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.
Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke. — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Total Mortality. — Time Frame: Total follow-up time of up to approximately 6 years.
Number of patients with an occurrence of death from any cause during the follow-up period.

This trial is recruiting at 410 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 410 Facilities & Contact Sites