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Cardiovascular Medicine - Active Clinical Trials
ACTIVE


PI:                    Dr. Greg Flaker
Coordinator:    Kathy Belew

Atrial Fibrillation Clopidogel Trial with Irbesartan for Prevention of Vascular Events

  • Active A intends to demonstrate the superiority of clopidogrel plus aspirin, compared to aspirin alone in patients either unable or unwilling to take an oral coagulant.
  • Active I is a placebo-controlled trial of irbesartan in all patients participating in Active A who do not require an angiotensin receptor blocking agent.

Inclusion:

  1. Evidence of permanent, paroxysmal or persistent atrial fibrillation.
  2. Evidence of high risk of vascular events including one or more of the following:
    • Age 75 or older
    • Being treated for systemic hypertension
    • Prior stroke, non-CNS systemic embolus or TIA
    • Left ventricular dysfunction with LVEF as demonstrated by echo or angiogram to be <45%
    • Peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio <0.9
  3. Age 55 - 74 years of age and either:
    • Diabetes mellitus requiring dug therapy
    • Or documented previous MI or document previous CAD

Exclusion:

  1. Requirement for clopidogral (such as recent coronary stent placement)
  2. Requirement for warfarin (such as prosthetic mechanical heart valve)
  3. Prior intolerance to aspirin or clopidogrel
  4. Documented active peptic ulcer disease within the previous 6 months
  5. Prior intracerebral hemorrhage
  6. Significant thrombocytopenia (plate <50,000/mm3)
  7. Psychosocial reason making participation in the study impractical
  8. Geographic reason making participation in the study impractical
  9. Ongoing alcohol abuse
  10. Mitral stenosis
  11. Pregnant or nursing women or women 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
  12. Severe co-morbid condition such that the patient is not expected to survive 6 months
  13. Patient is currently receiving an investigational pharmacologic agent

Actions:

  1. Determine if patient fits major study criteria.
  2. Determine if patient is interested in joining a clinical trial.
  3. Call Kathy Belew (beeper: 499-8063) and/or on-call research nurse (on-call beeper 499-8084) or Dr. Flaker to complete screening of patient.



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