CClinicalTrials.gg
CompletedNCT00461903CTAF-2Updated Feb 21, 2020

Efficacy of Perindopril to Prevent Recurrence of Atrial Fibrillation in Patients With Essential Hypertension

A Phase 3 interventional study of Perindopril in Essential Hypertension and Atrial Fibrillation, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-21.

Sponsored by Montreal Heart Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Essential Hypertension
  • Atrial Fibrillation

Keywords

  • essential hypertension
  • symptomatic paroxysmal or persistent atrial fibrillation
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 316 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 (for atrial fibrillation or any other arrhythmia)
  • Any medical condition that makes the patient an unsuitable candidate in the investigator's opinion
  • Any medical condition requiring ACE inhibitor or angiotensin-receptor blocker therapy (e.g. diabetes, known proteinuria of more than 300 mg per day)
  • Renal insufficiency with serum creatinine of 180 μmol/L or greater
  • Known bilateral renal artery stenosis
  • Serum potassium of 5.0 mmol/L or greater on recent laboratory exam
  • Positive pregnancy test (beta human chorionic gonadotropin [HCG] performed in women of childbearing potential)
  • Known intolerance to ACE inhibitor
  • Impossibility to discontinue certain treatments at selection visit
  • Known contraindication(s) to perindopril
  • Severe known liver disease including cirrhosis, biliary obstruction or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation more than 3 times the upper limit of normal
  • Use of ACE inhibitor or angiotensin-receptor blocker in the 3 months before the inclusion visit
  • Severely uncontrolled hypertension with SBP > 160 mmHg or DBP > 100 mmHg at the inclusion visit.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
316 participants (actual)

Study arms

  • Placebo comparator
    Placebo (for perindopril)

    Sugar pill manufactued to mimic perindopril

    Drug: Perindopril

  • Active comparator
    Perindopril

    Perindopril (coversyl) 4 mg tablets

    Drug: Perindopril

Interventions

  • DrugPerindopril

    Perindopril 4 mg or matching placebo , 1 tablet administrated once daily for the first 2 weeks. If tolarable, dosage increased to 8mg/day until the end of the study (

    Also known as: Coversyl

06

What researchers measure

Primary outcomes

  1. The primary efficacy endpoint will be time to first sustained recurrence of AF.

    1 month treatment adjustment 3 months of endpoint follow-up - M4 6 months of endpoint follow-up - M7 12 months of endpoint follow-up - M13

    Time frame: 12 months follow-up

Secondary outcomes

  1. 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).

    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 resources utilization (including hospitalisations for AF and cardioversion)

    Time frame: 6 months follow-up

07

Study locations

1 site
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
08

References and documents

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. doi: 10.1016/s0140-6736(02)11911-8. Erratum In: Lancet. 2003 Mar 22;361(9362):1060. PubMed 12493255 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00461903
Lead sponsor
Montreal Heart Institute
Collaborators
Servier
Responsible party
Sponsor
First posted
Apr 18, 2007
Start date
Dec 2007
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Feb 21, 2020

Study contacts

Mario Talajic, MD
principal investigator · Montreal Heart Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion