Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
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ClinicalTrials.gov Identifier: NCT03909022
Recruitment Status :
Active, not recruiting
First Posted : April 9, 2019
Last Update Posted : April 14, 2020
MDEpiNet Chapter Germany
Information provided by (Responsible Party):
Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf
This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of worsening limb symptoms or of major adverse cardiovascular events. The overall objective of this study is to gain a better understanding of patient characteristics, treatment patterns and outcomes in PAOD patients. For this purpose the investigators will analyze a patient population hospitalized either with intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) while taking prior PAOD-related diagnoses in the outpatient setting into account. In detail, we study differentials according to age, calendar time, sex, disease severity and hospital procedure. Data were extracted from available German health insurance claims.
Number of participants receiving best-medical-treatment [ Time Frame: at 12 months after discharge ]
Prevalence of the outpatient prescription of best medical treatment defined as picking up a medication at a pharmacy for a lipid-lowering, an antithrombotic, and an antihypertensive drug agent, within 12 months after index discharge for POAD according to information provided in health insurance claims data
Secondary Outcome Measures :
Number of participants deceased [ Time Frame: at 5 years after discharge ]
Rate of all-cause mortality after index discharge for POAD according to information provided in health insurance claims
Lower extremity amputation [ Time Frame: at 5 years after discharge ]
Rate of lower extremity amputation after index discharge for POAD according to information provided in health insurance claims
Number of participants with a myocardial infarction [ Time Frame: at 5 years after discharge ]
Rate of myocardial infarction after index discharge for POAD according to information provided in health insurance claims
Number of participants with a stroke or transient ischaemic attack [ Time Frame: at 5 years after discharge ]
Rate of stroke or TIA after index discharge for POAD according to information provided in health insurance claims
Number of participants with a major bleeding [ Time Frame: at 5 years after discharge ]
Rate of major bleeding provided in health insurance claims
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients older than 18 years of age. Treated in outpatient or inpatient facilities for symptomatic peripheral arterial occlussive disease.
First clinical diagnosis of symptomatic peripheral arterial occlusive disease (according to Fontaine classification, stages II, III and IV) after at least 5 years without such clinical diagnosis
At least 18 years of age
Incomplete information on sex, age, date of hospital discharge
Less than 5 years of insurance membership before index stay
Peters F, Kreutzburg T, Kuchenbecker J, Debus ES, Marschall U, L'Hoest H, and Behrendt CA. A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocolBMJ Surgery, Interventions, & Health Technologies 2020;2:e000020. doi: 10.1136/bmjsit-2019-000020
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):