Study identification

PURI

https://redirect.ema.europa.eu/resource/45320

EU PAS number

EUPAS31559

Study ID

45320

Official title and acronym

Observational study on the risk of myocardial infarction and stroke associated with proton pump inhibitor use (RiDe-PPI (MI & STROKE))

DARWIN EU® study

No

Study countries

Germany

Study description

This study is using ten years of claims database records provided by the largest statutory health insurance provider in Bavaria to estimate the effect of long-term intake of proton pump inhibitors on the risk of acute myocardial infarction and ischaemic stroke in adults. Our approach uses routinely collected health care data to conduct an observational study that emulates a clinical trial using clear inclusion criteria, period of enrolment, active treatment phases, and long-term follow up. The results of this study will provide additional evidence on the relationship between PPI use and the risk of myocardial infarction and stroke.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Sebastian-Edgar Baumeister

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Innovationsausschuss beim G-BA (Gemeinsamer Bundesausschuss)
Study protocol
Initial protocol

20190926_RiDe-PPI_(MI_STROKE)_Study_Protocol_(v1.0)

English (258 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable