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Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding

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ClinicalTrials.gov Identifier: NCT02514304
Recruitment Status : Recruiting
First Posted : August 3, 2015
Last Update Posted : October 24, 2017
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
John Eikelboom, Population Health Research Institute

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.

Condition or disease
Gastrointestinal Hemorrhage Cardiovascular Diseases

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- Pilot and Vanguard 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 - Pilot and Vanguard will recruit 300 case-control pairs from 3 centres in Hamilton, Ontario, 300 case-control pairs from 3 other centres across Canada and 800 case-control pairs from a minimum of 8 sites internationally will be recruited. Data will be collected on patient characteristics, medical history and, in cases, the work-up, management and outcomes after bleeding. Data from the INTERBLEED-Pilot and Vanguard will inform the design of the larger study that ultimately will help to develop new approaches to reducing the burden of bleeding-related CV events.


Study Type : Observational
Estimated Enrollment : 2800 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : September 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Myocardial infarction, stroke or death [ Time Frame: Up to one year ]

Secondary Outcome Measures :
  1. Change in functional status from baseline to 3 months [ Time Frame: 3 months ]
    Functional status measured by SAGE questionnaire

  2. Change in functional status from baseline to 12 months [ Time Frame: 12 months ]
    Functional status measured by SAGE questionnaire


Other Outcome Measures:
  1. Completeness of follow-up [ Time Frame: 3 months and 12 month ]
    Proportion of patients who complete follow up at 3 months and 12 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The community, inpatient/outpatient clinics (endoscopy clinics, stroke prevention clinics, cardiac/vascular clinics), emergency rooms
Criteria

Inclusion Criteria:

Cases

  • Age ≥ 18 years at enrollment
  • Written informed consent
  • Confirmed cardiovascular disease
  • Presented to the hospital with GI tract bleed

Controls

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514304


Contacts
Contact: Preston Thompson, BSc 905-527-4322 ext 40373 preston.thompson@phri.ca

Locations
Canada, Ontario
Hamilton Health Sciences, PHRI Recruiting
Hamilton, Ontario, Canada
Sponsors and Collaborators
Population Health Research Institute
Heart and Stroke Foundation of Ontario
Bristol-Myers Squibb
Daiichi Sankyo, Inc.
Investigators
Principal Investigator: John Eikelboom, MD Population Health Research Institute, McMaster University

Responsible Party: John Eikelboom, MD, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02514304     History of Changes
Other Study ID Numbers: INTERBLEED- Pilot and Vanguard
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases