Clinical trial NCT02514304: Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding
Official title: Study of Risk Factors for Gastrointestinal Bleeding and of the Determinants of Non-fatal and Fatal Cardiovascular Events After Gastrointestinal Bleeding in Patients Receiving Antithrombotic Therapy for Cardiovascular Prevention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Hemorrhage
Cardiovascular Diseases
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
name: Bristol-Myers Squibb
name: Daiichi Sankyo
First posted: 2015-08-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The community, inpatient/outpatient clinics (endoscopy clinics, stroke prevention clinics, cardiac/vascular clinics), emergency rooms

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Cases

* Age ≥ 18 years at enrollment
* Written informed consent
* Confirmed cardiovascular disease
* Present to the hospital with GI tract bleed or develop GI tract bleed in hospital

Controls

* Age ≥ 18 years at enrollment
* Written informed consent
* Confirmed cardiovascular disease

Primary outcomes:
measure: Myocardial infarction, stroke or death
timeFrame: Up to one year
Secondary outcomes:
measure: Change in functional status from baseline to 3 months
timeFrame: 3 months
measure: Change in functional status from baseline to 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, PHRI
state: Ontario
Study officials:
affiliation: Population Health Research Institute, McMaster University
name: John Eikelboom, MD
role: PRINCIPAL_INVESTIGATOR
References: