Trial Condition(s):

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

Estimating Incidence and Prevalence of Atherothrombotic Events in CAD, PAD and IS Patients on SOC Anti-Platelet Treatment: a Cohort Study in England

Bayer Identifier:

21309

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

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).

Inclusion Criteria
- 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
Exclusion Criteria
- 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
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Many locations

Many locations, United Kingdom

Trial Design