Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02514304
• Other study ID #: INTERBLEED
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Gastrointestinal Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, PHRI	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Population Health Research Institute	Bristol-Myers Squibb, Daiichi Sankyo, Inc., Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarction, stroke or death		Up to one year
Secondary	Change in functional status from baseline to 3 months	Functional status measured by SAGE questionnaire	3 months
Secondary	Change in functional status from baseline to 12 months	Functional status measured by SAGE questionnaire	12 months