Antithrombotic therapies are effective for prevention of cardiovascular (CV) events, but they cause bleeding. Emerging evidence indicates that extra-cranial bleeding is just as important as myocardial infarction as a marker of risk for subsequent non-fatal and fatal CV events, but this issue has not been prospectively studied.

If the association between bleeding and CV events is causal, prevention of bleeding, by targeting the risk factors, and prevention of the complications of bleeding, by targeting the causal pathways, could substantially reduce the burden of bleeding-related CV events.

The objectives of the INTERBLEED study are to determine, in patients with cardiovascular disease:
1. risk factors for gastrointestinal bleeding;
2. mechanisms linking gastrointestinal bleeding with risk of subsequent major adverse cardiovascular events;
3. impact of GI bleeding on functional outcomes.

Primary endpoint:

Composite of MI, stroke and death.

INTERBLEED Presentation - Download PDF
Study Type


Study Design

Multicenter, observational case-control and prospective cohort

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2015 - 2022



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