check_circleStudy Completed

Lower-Extremity Peripheral Artery Disease (LE-PAD)

Bayer Identifier:

19885

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Age ≥ 18 years
    - Referred to the hospital specifically for management of clinical LE-PAD of atherosclerotic origin
    - Consent to participate into the study

  • - 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
2513
Trial Dates
July 2018 - October 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
France

Primary Outcome

  • Describe demographic and clinical characteristics of patients with LE-PAD
    Age 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.
    date_rangeTime Frame:
    Retrospective analysis of data from 2004 to 2013
  • Rate of complications one year after the index date
    Death (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 amputations
    date_rangeTime Frame:
    Retrospective analysis of data from 2004 to 2013

Secondary Outcome

  • Proportion of patients responding to COMPASS-like population in the COPART registry
    date_rangeTime Frame:
    Retrospective analysis of data from 2004 to 2013
  • Describe cardiovascular treatment patterns at inclusion and at discharge of patients with LE-PAD
    Medicines prescribed (cardiovascular medications only)
    date_rangeTime Frame:
    Retrospective analysis of data from 2004 to 2013
  • Describe the factors associated with risk of complications in patients with LE-PAD
    date_rangeTime Frame:
    Retrospective analysis of data from 2004 to 2013

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
N/A

Additional Information

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