check_circleStudy Completed

Secondary cardiovascular (CV) prevention, Coronary artery disease (CAD), Peripheral arterial disease (PAD), Ischemic stoke (IS)

Bayer Identifier:

21309

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Estimating Incidence and Prevalence of Atherothrombotic Events in CAD, PAD and IS Patients on SOC Anti-Platelet Treatment: a Cohort Study in England

Trial purpose

The overall setting for this population was England – a Clinical Practice Research Datalink - Hospital Episode Statistics (CPRD-HES) linked population was used. CPRD Aurum contains routine-collected data from practices using Egton Medical Information Systems (EMIS) Web® electronic patient record system software and is available for all of the United Kingdom (UK) (England, Northern Ireland, Scotland and Wales). HES collects data from hospitals from England only (fully national). As such, the linkage was restricted to practices from England only.

The study enrollment period was from 1st January 2010 onwards, but CPRD has data dating back to 1st January 1995, used to access covariates of interest. The latest available data in HES were used in this study, corresponding to 31st October 2020.

Index date was considered the date of the first prescription of first SOC antiplatelet monotherapy in the study period (Aspirin for CAD and IS, and Clopidogrel for PAD).

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Prescribed stand of care (SOC) antiplatelet monotherapy as per case definition
    - Diagnosis of coronary artery disease or ischemic stroke or peripheral arterial disease, including carotid artery disease, not later than the date of first initiation of SOC antiplatelet monotherapy
    - Aged ≥ 18 years index date
    - At least 1 year of baseline data in clinical practice research datalink (CPRD) prior to index date
  • - Record of atrial fibrillation at index date
    - Pregnancy
    - Severe renal dysfunction (Stage V Chronic Kidney Disease or end stage kidney disease treated with renal replacement therapy)

Trial summary

Enrollment Goal
294428
Trial Dates
March 2021 - March 2022
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, United Kingdom

Primary Outcome

  • Major Adverse Cardiac Events (MACE) composite CV events: nonfatal stroke, nonfatal MI and CV death
    MI stands for myocardial infarction. CV stands for cardiovascular.
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Major Adverse Limb Events (MALE) composite CV events: acute or chronic limb ischaemia and amputation
    CV stands for cardiovascular.
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020

Secondary Outcome

  • Stand of care (SOC) regimens
    SOC regimens contain aspirin for coronary artery disease (CAD) and ischemic stroke (IS) and clopidogrel for peripheral arterial disease (PAD).
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Cause-specific cardiovascular hospitalizations
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Available follow-up time
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Demographic information
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Comorbidities at index date
    Comorbidities contain heart failure, hypertension, diabetes, previous myocardial infarction (MI), previous ischaemic stroke, malignancy, chronic kidney disease, dyslipidemia, prior cardiovascular (CV) procedure, polyvascular disease, previous amputation (for peripheral arterial disease [PAD] subcohort only)).
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Deprivation index at index date
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Prescribed medication by class at index date
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Alcohol use at index date
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Smoking status at index date
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
  • Lab values at index date
    date_rangeTime Frame:
    Retrospective analysis from 01 JAN 2010 to 31 OCT 2020

Trial design

Estimating Incidence and Prevalence of Atherothrombotic Events in CAD, PAD and IS Patients on SOC Anti-Platelet Treatment: a Cohort Study in England
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Health Services Research
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A