N/A
N=1,455
Prevention of Ischemic Events in Patients With Peripheral Arterial Disease
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT00761969 ↗Enrolled (actual)
1,455
Serious AEs
19.0%
Results posted
Nov 2015
Primary outcome: Primary: Incidence of Major Cardiovascular Events — 112; 47; 51; 17 participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- KRKA
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Major Cardiovascular Events |
112; 47; 51; 17; 50; 21 | <0.001 sig |
| SECONDARY Incidence of Revascularization Procedures |
183; 2; 64; 20; 31; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with PAD: ankle-brachial pressure index 80 years at inclusion
- Malignancy with a life expectancy < 5 years
- Atherothrombotic event within a month before inclusion (acute coronary syndrome, stroke or documented transient ischemic attack, critical limb ischemia)
- pregnancy
Data sourced from ClinicalTrials.gov (NCT00761969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.