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Completed

NCT Number: NCT00249795

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

The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:

  • have a systolic blood pressure of at least 110 mmHg
  • not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
  • no previous intolerance to angiotensin receptor blocking agents
  • no proven indication for angiotensin receptor blocking agents, unless an Angiotensin Converting Enzyme (ACE) inhibitor can be substituted

Exclusion criteria

Patients will be excluded from ACTIVE study if any of the following are present:

  • requirement for clopidogrel (such as recent coronary stent procedure)
  • requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
  • prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
  • documented peptic ulcer disease within the previous 6 months
  • prior intracerebral hemorrhage
  • significant thrombocytopenia (platelet count <50 x 10(9)/L)
  • psychosocial reason making study participation impractical
  • geographic reason making study participation impractical
  • ongoing alcohol abuse
  • mitral stenosis
  • pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study
  • severe comorbid condition such that the patient is not expected to survive 6 months
  • patient currently receiving an investigational pharmacologic agent
  • requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A

Treatment and study plan

Irbesartan

Drug

oral administration (tablets) once daily

Other names: Aprovel®

Placebo

Drug

oral administration (tablets) once daily

Primary outcomes

  1. 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

    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).

  2. 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

    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.

Secondary outcomes

  1. First Occurrence of Stroke

    Time frame: Median follow-up of 4.5 years

    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.

  2. Death From Any Cause

    Time frame: Median follow-up of 4.5 years

    The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.

  3. First Occurrence of Any Heart Failure (HF) Episode

    Time frame: Median follow-up of 4.5 years

    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).

  4. First Hospitalisation for Heart Failure (HF)

    Time frame: Median follow-up of 4.5 years

    The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.

  5. First Hospitalisation for Other Cardiovascular (CV) Cause

    Time frame: Median follow-up of 4.5 years

    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).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation

Acronym: ACTIVE I

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Nov 7, 2005
Registry last updated
Oct 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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