A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease "ARRIVE"

Completed

Phase 3 Results

Trial Description

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied. However, the overall risk level of the study populations was low (< 10% 10-year CHD risk). The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to take aspirin or placebo; follow-up for approximately 5 years after being enrolled in trial.

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to first occurrence of the composite outcome of MI, stroke or cardiovascular death.
Secondary Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke; time to first occurrence of the individual components of the primary: MI, stroke or cardiovascular death; time to occurrence/ incidence of all cause mortality; time to first occurrence/ incidence of all cancers, excluding non melanoma skin cancer;time to first occurrence/ incidence of colon cancer; incidence of MI, stroke and CV death.
Primary Time to first occurrence of the composite outcome of MI, stroke or cardiovascular death Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Time to first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke or cardiovascular death Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Time to incidence of all cause mortality Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Time to first occurrence of/ incidence of all cancers, excluding non melanoma skin cancer Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Time to first occurrence of/ incidence of colon cancer Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Incidence of MI, stroke and CV death separately Approximately 5 years of follow-up (duration of planned treatment phase) No
Secondary Incidence of treatment-emergent adverse events (observed and reported), and changes in the physical examination findings, weight, and vital signs Approximately 5 years of follow-up (duration of planned treatment phase) Yes
Primary Time to first occurrence of the composite outcome of MI, stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack) Approximately 6 years of follow-up (duration of planned treatment phase) No
Secondary Time to first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA or TIA Approximately 6 years of follow-up (duration of planned treatment phase) No
Secondary Incidence of MI, stroke, UA, TIA and CV death separately Approximately 6 years of follow-up (duration of planned treatment phase) No

Sponsors