Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

• First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
  
  
• First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.
  
  

• First Occurrence of Stroke [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.
  
  
• Death From Any Cause [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.
  
  
• First Occurrence of Any Heart Failure (HF) Episode [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
  
  
• First Hospitalisation for Heart Failure (HF) [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.
  
  
• First Hospitalisation for Other Cardiovascular (CV) Cause [ Time Frame: Median follow-up of 4.5 years ] [ Designated as safety issue: No ]
  The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
  
  

ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events.

Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:

• ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
• ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).

Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.