Peripheral Arterial Disease Clinical Trial
— PID-PABOfficial title:
Prevention of Ischemic Events in Patients With Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice
Verified date | November 2015 |
Source | KRKA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Agency for Medicinal Products - Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1455 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovenia | Department of Vascular Diseases, University of Ljubljana Medical Center | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
KRKA | Krka, d.d., Novo mesto, Slovenia, University Medical Centre Ljubljana, University of Ljubljana School of Medicine, Slovenia |
Slovenia,
Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. Erratum in: BMJ 2002 Jan 19;324(7330):141. — View Citation
Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6. — View Citation
De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomér K, Perk J, Pyörälä K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Major Cardiovascular Events | Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia. | 5 years: | No |
Secondary | Incidence of Revascularization Procedures | Incidence of coronary, carotid and peripheral arterial revascularization procedures | 5 years | No |
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