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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by KRKA.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Krka, d.d., Novo mesto, Slovenia
Information provided by:
KRKA
ClinicalTrials.gov Identifier:
NCT00761969
First received: September 28, 2008
Last updated: September 29, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Other: Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Ischemic Events in Patients With Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice

Resource links provided by NLM:


Further study details as provided by KRKA:

Primary Outcome Measures:
  • incidence of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, ischemic stroke, acute limb ischemia) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of revascularization procedures (coronary, carotid, peripheral arterial) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood (16 ml) for analysis of inflammatory markers (from serum) and genotyping, to be correlated with clinical outcomes.

Anonymity of patients is proveded by coding the samples and the patients clinical records.


Estimated Enrollment: 1600
Study Start Date: December 2004
Estimated Study Completion Date: June 2011
Groups/Cohorts Assigned Interventions
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 (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
Other Name: -NA-
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 (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
Other Name: -NA-

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.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761969

Locations
Slovenia
Department of Vascular Diseases, University of Ljubljana Medical Center
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
KRKA
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Breda Barbic Zagar, MD, Medical Director, Krka, d.d., Krka, d.d., Novo Mesto, Slovenia
ClinicalTrials.gov Identifier: NCT00761969     History of Changes
Other Study ID Numbers: PID-PAB
Study First Received: September 28, 2008
Last Updated: September 29, 2008
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by KRKA:
peripheral arterial disease
secondary prevention
cardiovascular /atherothrombotic events
European guidelines on cardiovascular disease prevention in clinical practice

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014