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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Peripheral Arterial Disease
Intervention Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice
Enrollment 1455
Recruitment Details

This study was conducted by 85 primary care physicians-researchers from Slovenia, acountry with a population of about 2 million. Participating physicians were educated on cardiovascular disease prevention according to the European guidelines attended annual progress report meetings and were visited at least once a year by a study monitor.

Pre-assignment Details  
Arm/Group Title Peripheral Arterial Disease Control
Hide Arm/Group Description

Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.

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 .

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

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 .

Period Title: Overall Study
Started 742 713
Completed 542 573
Not Completed 200 140
Reason Not Completed
Death             112             47
Lost to Follow-up             88             93
Arm/Group Title Peripheral Arterial Disease Control Total
Hide Arm/Group Description

Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.

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).

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

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).

Total of all reporting groups
Overall Number of Baseline Participants 742 713 1455
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 742 participants 713 participants 1455 participants
65.1  (8.8) 64.7  (9.2) 64.9  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 742 participants 713 participants 1455 participants
Female
277
  37.3%
275
  38.6%
552
  37.9%
Male
465
  62.7%
438
  61.4%
903
  62.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovenia Number Analyzed 742 participants 713 participants 1455 participants
742 713 1455
1.Primary Outcome
Title Incidence of Major Cardiovascular Events
Hide Description Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.
Time Frame 5 years:
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peripheral Arterial Disease Control
Hide Arm/Group Description:

Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.

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).

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

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).

Overall Number of Participants Analyzed 742 713
Measure Type: Number
Unit of Measure: participants
Death of all causes 112 47
Cardiovascular death 51 17
Non-fatal myocardial infarction 50 21
Non-fatal ischemic stroke 22 14
Critical limb ischemia 11 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peripheral Arterial Disease, Control
Comments Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression – the outcome being the number of events per person-year.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Revascularization Procedures
Hide Description Incidence of coronary, carotid and peripheral arterial revascularization procedures
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peripheral Arterial Disease Control
Hide Arm/Group Description:

Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.

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).

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

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).

Overall Number of Participants Analyzed 742 713
Measure Type: Number
Unit of Measure: participants
Peripheral arterial revascularization 183 2
Coronary revascularization 64 20
carotid revascularization 31 8
Abdominal aortic revascularization 6 0
Time Frame Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
Adverse Event Reporting Description At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
 
Arm/Group Title Peripheral Arterial Disease Control
Hide Arm/Group Description

Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =< 0.90.

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).

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

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).

All-Cause Mortality
Peripheral Arterial Disease Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peripheral Arterial Disease Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   195/742 (26.28%)      82/713 (11.50%)    
Cardiac disorders     
Non-fatal myocardial infarction   50/742 (6.74%)  50 21/713 (2.95%)  21
General disorders     
Death of all causes   112/742 (15.09%)  112 47/713 (6.59%)  47
Nervous system disorders     
Non-fatal ischemic stroke   22/742 (2.96%)  22 14/713 (1.96%)  14
Vascular disorders     
Critical limb ischemia   11/742 (1.48%)  11 0/713 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Peripheral Arterial Disease Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   284/742 (38.27%)      30/713 (4.21%)    
Vascular disorders     
Peripheral arterial revascularization procedure  [1]  183/742 (24.66%)  183 2/713 (0.28%)  2
Coronary revascularization procedure  [2]  64/742 (8.63%)  64 20/713 (2.81%)  20
Carotid revascularization  [3]  31/742 (4.18%)  31 8/713 (1.12%)  8
Abdominal aortic revascularization  [4]  6/742 (0.81%)  6 0/713 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Endovascular or surgical peripheral arterial revascularization
[2]
Percutaneous coronary intervention or surgical coronary revascularization
[3]
Surgical carotid endarterectomy or carotid artery stenting
[4]
Surgical aortic repair or endovascular aortic repair (EVAR)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ales Blinc, MD, DSc
Organization: Department of Vascular Diseases, University of Ljubljana Med Ctr
Phone: +386 1 522 80 32
Publications:
Responsible Party: KRKA
ClinicalTrials.gov Identifier: NCT00761969     History of Changes
Other Study ID Numbers: PID-PAB
First Submitted: September 28, 2008
First Posted: September 30, 2008
Results First Submitted: September 29, 2015
Results First Posted: November 17, 2015
Last Update Posted: November 17, 2015