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).
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
AllAge
18 - N/ATrial summary
Enrollment Goal
294428Trial Dates
March 2021 - March 2022Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, United Kingdom |
Primary Outcome
- Major Adverse Cardiac Events (MACE) composite CV events: nonfatal stroke, nonfatal MI and CV deathMI 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 amputationCV stands for cardiovascular.date_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
Secondary Outcome
- Stand of care (SOC) regimensSOC 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 hospitalizationsdate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Available follow-up timedate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Demographic informationdate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Comorbidities at index dateComorbidities 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 datedate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Prescribed medication by class at index datedate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Alcohol use at index datedate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Smoking status at index datedate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
- Lab values at index datedate_rangeTime Frame:Retrospective analysis from 01 JAN 2010 to 31 OCT 2020
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
Health Services ResearchAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A