Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02514304 |
| Other study ID # |
INTERBLEED |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
September 2022 |
| Source |
Population Health Research Institute |
| Contact |
Leah Hamilton, BSc |
| Phone |
905-527-4322 |
| Email |
Leah.Hamilton[@]phri.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this multicenter, two component observational and standardized case-control
study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective
3-month and 12-month follow-up to examine outcomes and their possible causes.
Description:
Antithrombotic therapies are effective for prevention of cardiovascular (CV) events but 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. Progress in developing these approaches has been
limited by a knowledge gap. Known risk factors do not fully explain bleeding risk and the
investigators do not understand the mechanisms linking bleeding with adverse outcome and
whether the association is causal.
One-half of bleeds that lead to CV events in patients receiving antithrombotic therapy arise
in the GI tract. INTERBLEED plans to explore risk factors for GI bleeding, and outcomes after
GI bleeding, in this well-circumscribed and important group using a case-control design with
prospective 3 month and 12 month follow-up.
Specific objectives are to: (1) identify risk factors for GI bleeding and estimate their
population attributable risk; (2) determine the risk of non-fatal and fatal CV events and
functional outcomes after GI bleeding; and (3) explore the possible mechanisms linking GI
bleeding with CV outcome.
INTERBLEED will recruit 2500 case-control pairs from centres in Argentina, Belgium, Brazil,
China, Ireland and the Netherlands. Data will be collected on patient characteristics,
medical history and, in cases, the work-up, management and outcomes after bleeding. The
INTERBLEED results will help to develop new approaches to reducing the burden of
bleeding-related CV events.
