Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany

• ClinicalTrials.gov Identifier: NCT03909022
• Recruitment Status: Unknown
• First Posted: April 9, 2019
• Last Update Posted: April 14, 2020
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: GermanVasc; MDEpiNet Chapter Germany
• Information provided by (Responsible Party): Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf

Tracking Information

• First Submitted Date: April 2, 2019
• First Posted Date: April 9, 2019
• Last Update Posted Date: April 14, 2020
• Actual Study Start Date: January 1, 2008
• Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2019)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
• Official Title: Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients older than 18 years of age. Treated in outpatient or inpatient facilities for symptomatic peripheral arterial occlussive disease.

Condition

• Peripheral Artery Disease
• Intermittent Claudication
• Critical Limb Ischemia

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Peters F, Kreutzburg T, Kuchenbecker J, Debus S, Marschall U, L'Hoest H, Behrendt CA. A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocol. BMJ Surg Interv Health Technol. 2020 Jan 27;2(1):e000020. doi: 10.1136/bmjsit-2019-000020. eCollection 2020.
• Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. Editor's Choice - Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis. Eur J Vasc Endovasc Surg. 2020 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8.
• Peters F, Kreutzburg T, Riess HC, Heidemann F, Marschall U, L'Hoest H, Debus ES, Sedrakyan A, Behrendt CA. Editor's Choice - Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):421-429. doi: 10.1016/j.ejvs.2020.05.001. Epub 2020 Jul 12.
• Peters F, Kuchenbecker J, Acar L, Marschall U, L'Hoest H, Lareyre F, Spanos K, Behrendt CA. Antithrombotic Treatment Patterns of Patients with Symptomatic Peripheral Arterial Occlusive Disease in Germany: Evidence from Health Insurance Claims Data. J Clin Med. 2022 Sep 16;11(18):5455. doi: 10.3390/jcm11185455.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 7, 2019): 60000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2021
• Estimated Primary Completion Date: March 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

1. 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

2. At least 18 years of age

   Exclusion Criteria:

3. Incomplete information on sex, age, date of hospital discharge
4. Less than 5 years of insurance membership before index stay

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03909022
• Other Study ID Numbers: GermanVasc2019_023
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Christian Behrendt, Universitätsklinikum Hamburg-Eppendorf
• Original Responsible Party: Same as current
• Current Study Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Original Study Sponsor: Same as current

Collaborators

• GermanVasc
• MDEpiNet Chapter Germany

Investigators

• Principal Investigator: Christian-Alexander Behrendt, MD Dr.; University Medical Center Hamburg-Eppendorf, Working Group GermanVasc

• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: April 2020