Prevention of Ischemic Events in Patients With Peripheral Arterial Disease (PID-PAB)

November 12, 2015 updated by: KRKA

Prevention of Ischemic Events in Patients With Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice

The PID-PAB study aims to test the efficacy of the European Guidelines on Cardiovascular Disease Prevention in patients with peripheral arterial disease. Survival, the rate of major atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and the incidence of revascularization procedures will be compared between a group of patients with stable peripheral arterial disease (PAD) and age- and sex-matched control subjects without PAD. Both groups will be receiving up-to-date medical care according to their cardiovascular risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. Yearly follow-up is planned for 5 years. The PID PAB study aims to test (a) whether stable PAD is still an adverse prognostic indicator in spite of contemporary preventive measures, and (b) to what extent do contemporary preventive measures improve the prognosis of patients with PAD in comparison to historic controls, representing the natural history of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The observational study Prevention of Ischemic Events in Patients with Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention (Slovenian acronym of the study: PID-PAB)aims to test the efficacy of the European Guidelines on Cardiovascular Disease Prevention in patients with peripheral arterial disease, who have an even higher mortality rate than patients with isolated coronary artery disease or cerebrovascular disease when left to the natural course of the disease. The PID-PAB study will compare the rates of survival, major atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and revascularization procedures between a group of patients with stable peripheral arterial disease (PAD) and a control group of age- and sex-matched subjects without PAD. Both groups will be receiving up-to-date medical care (including life-style advice and prescription of cardioprotective medication) according their cardiovascular risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. PAB is defined by a reduced ankle-brachial pressure index of =< 0.90, while absence of PAD is defined by palpable pedal pulses and a normal ankle-brachial index (0.91-1.30). Exclusion criteria are: age < 40 or > 80 years at inclusion, active cancer or other disease with a life expectancy of les than 5 years, any major atherothrombotic event in 30 days prior to enrollment, and pregnancy. All subjects will be followed annually for 5 years by comprehensive medical examinations. The settings of the study are primary care facilities in Slovenia, European Union. The target size of each group is 1000 subjects, i.e., 5000 patient years. The number of participating physicians-researchers is estimated at 100, with a goal for each physician to recruit 10 patients with PAD and 10 age- and sex-matched controls. The study is coordinated by a steering committee consisting of researchers from the Department of Vascular Diseases at the University of Ljubljana Medical Centre, Institute of Biomedical Informatics at the University of Ljubljana School of Medicine, Department of Family Medicine at the University of Ljubljana School of Medicine and the pharmaceutical company Krka, Slovenia, who is also the sponsor of the study. The protocol of the study has been approved by the Committee of Medical Ethics of the Republic of Slovenia.

The PID PAB study aims to answer the questions:

  1. Is stable PAD is still an adverse prognostic indicator in spite of contemporary preventive measures?
  2. To what extent do contemporary preventive measures improve the prognosis of patients with PAD in comparison to historic controls (described in earlier reports on the natural history of PAD ? We expect to still find a significant difference in the rate of cardiovascular events between patients with PAD and their peers without PAD, but we hypothesize that contemporary preventive measures will strongly attenuate the adverse prognosis of PAD regarding survival and major atherothrombotic events in comparison to the natural history of the disease.

Study Type

Observational

Enrollment (Actual)

1455

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Department of Vascular Diseases, University of Ljubljana Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stable, objectively confirmed PAD, recruited from primary care settings in Slovenia, Europe.

Control subjects of comparable age- and sex-distribution, without PAD, recruited from primary care settings in Slovenia, Europe.

Description

Inclusion Criteria:

  1. Patients with PAD: ankle-brachial pressure index <= 0.90
  2. Controls: palpable pedal pulses, ankle-brachial pressure index 0.91-1.30

Exclusion Criteria:

  1. Age < 40 or > 80 years at inclusion
  2. Malignancy with a life expectancy < 5 years
  3. Atherothrombotic event within a month before inclusion (acute coronary syndrome, stroke or documented transient ischemic attack, critical limb ischemia)
  4. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PAB
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice
Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice.
Control
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice
Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Major Cardiovascular Events
Time Frame: 5 years:
Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.
5 years:

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Revascularization Procedures
Time Frame: 5 years
Incidence of coronary, carotid and peripheral arterial revascularization procedures
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KRKA

Collaborators

University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Krka, d.d., Novo mesto, Slovenia

Investigators

  • Principal Investigator: Ales Blinc, MD, DSc, Dept of Vascular Diseases, University of Ljubljana Med Ctr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 28, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID-PAB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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