Trial Condition(s):
Lower-Extremity Peripheral Artery Disease (LE-PAD)
Using the French COPART registry database this study gathers French real life data of patients suffering from a health condition where narrowed arteries reduce blood flow in the part of the body from the hip to the toes
Bayer Identifier:
19885
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of the study is to generate French real life data of patients suffering from a health condition where narrowed arteries reduce blood flow in the part of the body from the hip to the toes (Lower extremity peripheral artery disease, LE-PAD). By using real life data included in the French COPART registry database investigators want to learn more about the characteristics of this patient population and estimate the rate of complications such as heart disease, bleeding, amputation.
Inclusion Criteria
- Age ≥ 18 years - Referred to the hospital specifically for management of clinical LE-PAD of atherosclerotic origin - Consent to participate into the study
Exclusion Criteria
- Follow-up considered improbable - Arterial occlusive disease not related to atherosclerosis (endofibrosis, inflammatory arterial disease, Buerger´s disease, entrapment syndromes, etc.) - Acute ischema without lower-limb atherosclerosis (embolic) - patients refusing to participate
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
ORPAD-COPART – Observational Retrospective French registry study on Peripheral Artery Disease using the French COPART registry database.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Describe demographic and clinical characteristics of patients with LE-PADAge Gender BMI (categorical) Smoking status Major comorbidities and previous medical histories (including coronary heart disease, acute coronary syndrome), cerebrovascular disease (transient ischemic attack and stroke), hypertension, dyslipidemia, history of revascularization and type, chronic renal disease, chronic obstructive pulmonary disease, diabetes. Concomitant medications (including anti-platelet agents (aspirin, clopidogrel, prasugrel), anti-coagulants, statins, ACE inhibitors, angiotensin receptor blockers, beta-blockers, anti-diabetic medications) at inclusion and at discharge. Clinical presentation of LE-PAD at inclusion (i.e. intermittent claudication, ischemic pain at rest, ulceration, gangrene). Date of diagnosis of PAD.Timeframe: Retrospective analysis of data from 2004 to 2013
- Rate of complications one year after the index dateDeath (cardiovascular death and all causes). Primary diagnosis of cardiovascular event (MI or ischemic stroke). Medicines prescribed (cardiovascular medications only). Major bleedings (ISTH definition). Lower extremity revascularization. Coronary and carotid revascularizations. Major and minor amputationsTimeframe: Retrospective analysis of data from 2004 to 2013
Secondary Outcome
- Proportion of patients responding to COMPASS-like population in the COPART registryTimeframe: Retrospective analysis of data from 2004 to 2013
- Describe cardiovascular treatment patterns at inclusion and at discharge of patients with LE-PADMedicines prescribed (cardiovascular medications only)Timeframe: Retrospective analysis of data from 2004 to 2013
- Describe the factors associated with risk of complications in patients with LE-PADTimeframe: Retrospective analysis of data from 2004 to 2013
Additional Information
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