ACTIVE I
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events
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Status:
This study is ongoing, but not recruiting participants.
Purpose:
The purpose of this study is to determine if irbesartan 300mg once daily (od) compared to placebo tablet (an inert substance) will reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death during approximately 3 years of follow-up in patients with atrial fibrillation and with a systolic blood pressure of at least 110 mmHg associated with at least one major risk of vascular events because they are already enrolled into ACTIVE A or ACTIVE W study.
Interventions:
irbesartan
An angiotensin II receptor (AT1 subtype) antagonist and a non-peptide compound
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Placebo
A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
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Location(s):
New Jersey,Argentina, Australia, Austria,
Belgium, Brazil, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy,
Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, United Kingdom,
Year Started:
2003
Design:
Interventional, Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study.
Inclusion Criteria
Should fulfill first the eligibility criteria for Active A or Active W study and :
• to do not have a systolic blood pressure above 110 mm Hg;
• not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent;
• no previous intolerence to angiotensin receptor blocking agents;
• no proven indication for angiotensin receptor blocking agents, unless an ACE inhibitor can be substituted.
Exclusion Criteria
Patients will be excluded from ACTIVE if any of the following are present:
• requirement for clopidogrel (such as recent coronry stent procedure)
• requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
• prior intolerance to ASA or clopidogrel;
• documented peptic ulcer disease within the previous 6 months;
• prior intracerebral hemorrhage;
• significant thrombocytopenia; (platelet count <50 x 10(9)/L)
• psyghosocial 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-COX-2 inhibitor NSAID therapy unless willing enrolled in ACTIVE A.
Patient Involvement:
Patients will be randomized to one of two arms: Irbesartan
oral administration of 300mg once daily or placebo once daily oral.
Primary Outcome:
First composite outcome of stroke, myocardial infarction or vascular death. Second composite outcome of stroke, myocardial infarction, vascular death or hospitalization for heart failure.
Secondary Outcome:
Total mortality, stroke, hospitalization for heart failure and other heart failure episodes defined as evidence of symptoms or signs of heart failure (with or without hospitalization).
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 6/8/2009
Reviewed on: 09/02/2009.
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