NCT02514304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,745

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

8.3 years

First QC Date

July 29, 2015

Last Update Submit

July 28, 2025

Conditions

Gastrointestinal HemorrhageCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarction, stroke or death

    Up to one year

Secondary Outcomes (2)

  • Change in functional status from baseline to 3 months

    3 months

  • Change in functional status from baseline to 12 months

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The community, inpatient/outpatient clinics (endoscopy clinics, stroke prevention clinics, cardiac/vascular clinics), emergency rooms

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences, PHRI

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Gastrointestinal HemorrhageCardiovascular Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Eikelboom, MD

    Population Health Research Institute, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 3, 2015

Study Start

September 1, 2015

Primary Completion

December 15, 2023

Study Completion

December 1, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations

CA(1)