NCT00788736

Brief Summary

The main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,537

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
3 countries

12 active sites

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

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

8 years

First QC Date

November 10, 2008

Last Update Submit

October 25, 2016

Conditions

Venous Thromboembolism

Keywords

venous thromboembolismlong-term oral anticoagulant therapywarfarinbleeding riskclinical prediction rulepredictorsdeep vein thrombosispulmonary embolismvitamin k antagonistside effect

Outcome Measures

Primary Outcomes (1)

  • Major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria)

    ongoing for 3-7 years with follow-up phone calls at 6-month intervals

Secondary Outcomes (3)

  • Clinically relevant non-major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria)

    ongoing for 3-7 years with follow-up phone calls at 6-month intervals

  • recurrent venous thromboembolism

    ongoing for 3-7 years with follow-up phone calls at 6-month intervals

  • death (all causes)

    ongoing for 3-7 years with follow-up phone calls at 6-month intervals

Eligibility Criteria

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

Outpatients being treated for venous thromboembolism

You may qualify if:

  • \>=18 years old
  • provoked or unprovoked venous thromboembolism
  • objectively confirmed venous thromboembolism
  • treated with an oral anticoagulant(vitamin K antagonist or new oral anticoagulant) for at least 3 months with plans to continue long-term
  • if taking a vitamin K antagonist; INR target is between 2.0-3.0
  • if taking a vitamin K antagonist; must have taken it for the last 3 consecutive weeks (minimum)

You may not qualify if:

  • major bleeding while taking oral anticoagulants
  • active bleeding at study enrollment
  • active cancer - current or at the time of VTE diagnosis
  • unable to provide written informed consent
  • refusal to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Lahey Clinic

Burlington, Massachusetts, MA01805, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Centre

Montreal, Quebec, H3T 1M5, Canada

Location

Hopital du Sacre Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Oxford Haemophilia and Thrombosis Centre, Churchill Hospital

Oxford, 0X3 7LJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects may consent to optional DNA and plasma banking

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Phil S Wells, MD, MSc

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(2)CA(9)GB(1)