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

NCT00461903 | Completed Phase 3 DMC

• 1 other identifier: IC4-9490-123-CAN
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension; Atrial Fibrillation

Keywords

essential hypertension; symptomatic paroxysmal or persistent atrial fibrillation

Outcome Measures

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

  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).

  6 months follow-up

Study Arms (2)

Placebo (for perindopril)

PLACEBO COMPARATOR

Sugar pill manufactued to mimic perindopril

Drug: Perindopril

Perindopril

ACTIVE COMPARATOR

Perindopril (coversyl) 4 mg tablets

Drug: Perindopril

Interventions

Perindopril DRUG

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

Perindopril; Placebo (for perindopril)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Servier: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

• 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.

  PMID: 12493255 RESULT

MeSH Terms

Conditions

Essential Hypertension; Atrial Fibrillation

Interventions

Perindopril

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mario Talajic, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CA (1)