Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential H… (NCT00461903) | Clinical Trial Compass
CompletedPhase 3
Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension
Canada316 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must be age 18 years or older.
* Patients may be either male or female without childbearing potential (or with adequate contraception).
* Patients must have a current diagnosis of essential hypertension with systolic blood pressure (SBP) ≤ 160 mmHg and diastolic blood pressure (DBP) ≤ 100 mmHg at the time of inclusion visit AND
* Patients must have had at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within the preceding six months:
* With an indication for cardioversion in the case of persistent AF
* With electrocardiogram (ECG) documentation of AF
* With duration of an AF episode of at least 10 minutes
Exclusion Criteria:
* Unlikely to co-operate in the study
* Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (patients must have adequate contraception as determined by the investigator).
* Alcoholism or drug abuse
* Participation in another study at the same time or within 30 days of randomisation.
* Left ventricular systolic dysfunction with an ejection fraction of 45% or less
* Myocardial infarction within the past month prior to the selection visit
* Cardiac or thoracic surgery within the past 3 months or likely to be performed during the trial
* Chronic AF (continuously present for \> 6 months)
* AF secondary to an acute reversible condition (e.g. post-operative atrial fibrillation, hyperthyroidism)
* Currently requiring class I or class III anti-arrhythmic drug therapy…
What they're measuring
1
The primary efficacy endpoint will be time to first sustained recurrence of AF.