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| Tracking Information | |||||
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| First Received Date ICMJE | April 16, 2007 | ||||
| Last Updated Date | July 16, 2007 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
The primary efficacy endpoint will be time to first sustained recurrence of AF. | ||||
| Original Primary Outcome Measures ICMJE |
The primary efficacy endpoint will be time to first sustained recurrence of AF | ||||
| Change History | Complete list of historical versions of study NCT00461903 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Secondary efficacy endpoints will be the proportion of patients without AF throughout the 6 months of follow-up, number of documented relapses of AF, and health care resource utilization (including hospitalisations for AF and cardioversions). | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Determine the Efficacy of Perindopril to Prevent the Recurrence of Atrial Fibrillation in Patients With Essential Hypertension | ||||
| Official Title ICMJE | A Prospective, Randomized, Double-Blind Placebo-Controlled Study to Determine the Efficacy of 8 mg/Day Oral Perindopril to Prevent the Recurrence of Atrial Fibrillation in Patients With Essential Hypertension | ||||
| Brief Summary | The purpose of this 7- to 13-month study is to determine the efficacy of 8 mg/day oral perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential hypertension. |
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| Detailed Description | Hypertension affects approximately 50 million individuals in the United States and approximately 1 billion individuals worldwide. As the population ages, the prevalence of hypertension is expected to increase even further unless broad and effective preventive measures are implemented. Recent data from the Framingham Heart Study suggest that individuals who are normotensive at 55 years of age have a 90% lifetime risk for developing hypertension. The relationship between blood pressure (BP) and risk of cardiovascular disease (CVD) events is continuous, consistent, and independent of other risk factors. The higher the BP, the greater is the chance of myocardial infarction, heart failure (HF), stroke, and kidney disease. Atrial fibrillation (AF) is also a major health problem and has been described as one of two emerging cardiovascular epidemics at the turn of the century. It is the most frequent cardiac arrhythmia, affecting 5% of individuals aged > 65 years, and it is associated with an increased risk of stroke and a doubling of all-cause mortality. The loss of effective atrial contraction may result in impaired cardiac performance, reduced exercise tolerance and congestive heart failure. In addition, patients with atrial fibrillation often have disabling palpitations. Perindopril (Coversyl) is an angiotensin-converting enzyme (ACE) inhibitor with demonstrated efficacy in controlling hypertension. There are several lines of evidence suggesting that ACE inhibition may reduce the incidence of new-onset AF as well as AF recurrences. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Coversyl (perindopril) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. Erratum in: Lancet. 2003 Mar 22;361(9362):1060. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 320 | ||||
| Estimated Completion Date | August 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00461903 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | IC4-9490-123-CAN | ||||
| Study Sponsor ICMJE | Montreal Heart Institute | ||||
| Collaborators ICMJE | Servier | ||||
| Investigators ICMJE |
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| Information Provided By | Montreal Heart Institute | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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