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

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ClinicalTrials.gov Identifier: NCT00761969
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Sponsor:
Collaborators:
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Krka, d.d., Novo mesto, Slovenia
Information provided by (Responsible Party):
KRKA

Tracking Information
First Submitted Date September 28, 2008
First Posted Date September 30, 2008
Results First Submitted Date September 29, 2015
Results First Posted Date November 17, 2015
Last Update Posted Date November 17, 2015
Study Start Date December 2004
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2015)
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.
Original Primary Outcome Measures
 (submitted: September 29, 2008)
incidence of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, ischemic stroke, acute limb ischemia) [ Time Frame: 5 years ]
Change History Complete list of historical versions of study NCT00761969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 12, 2015)
Incidence of Revascularization Procedures [ Time Frame: 5 years ]
Incidence of coronary, carotid and peripheral arterial revascularization procedures
Original Secondary Outcome Measures
 (submitted: September 29, 2008)
incidence of revascularization procedures (coronary, carotid, peripheral arterial) [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevention of Ischemic Events in Patients With Peripheral Arterial Disease
Official Title Prevention of Ischemic Events in Patients With Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

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.

Condition Peripheral Arterial Disease
Intervention 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.
Study Groups/Cohorts
  • PAB
    Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.
    Intervention: Other: Implementation of 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
    Intervention: Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 12, 2015)
1455
Original Estimated Enrollment
 (submitted: September 29, 2008)
1600
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00761969
Other Study ID Numbers PID-PAB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party KRKA
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
PRS Account KRKA
Verification Date November 2015