NCT00720915

Brief Summary

The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
4 countries

13 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

First Submitted

Initial submission to the registry

July 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

8.3 years

First QC Date

July 21, 2008

Last Update Submit

December 12, 2016

Conditions

Deep Vein ThrombosisPulmonary Embolism

Keywords

unprovoked deep vein thrombosisunprovoked pulmonary embolismanticoagulant therapy

Outcome Measures

Primary Outcomes (4)

  • Suspected Recurrent DVT

    up to 7 years

  • Suspected (recurrent) pulmonary embolism

    up to 7 years

  • Bleeding

    up to 7 years

  • Death

    up to 7 years

Study Arms (2)

No Anticoagulant Therapy

OTHER

No Anticoagulant Therapy

Other: Discontinue anticoagulant therapy (Negative d-dimer)

Anticoagulant Therapy

OTHER

Continue on anticoagulant therapy

Other: Continue on anticoagulant therapy (positive d-dimer)

Interventions

Discontinue anticoagulant therapy (Negative d-dimer)OTHER

Patients with negative d-dimer discontinue long-term anticoagulant therapy.

No Anticoagulant Therapy
Continue on anticoagulant therapy (positive d-dimer)OTHER

Patients with positive d-dimer continue or re-start on anticoagulant therapy

Anticoagulant Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be \>= 18 years of age
  • Have had ONE episode of unprovoked proximal DVT and/or PE
  • Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)

You may not qualify if:

  • Another indication for long-term anticoagulation (e.g., atrial fibrillation)
  • A high risk of bleeding as evidenced by any of the following:
  • Age greater than 75 years
  • Previous episode of major bleeding where the cause was not effectively treated
  • Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10\^9 /L
  • Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl)
  • Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl)
  • Active peptic ulcer disease
  • Poor compliance with, or control of, anticoagulant therapy during initial treatment
  • Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)
  • A vena caval filter
  • Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed
  • Has a life expectancy less than 5 years
  • Is unable to attend follow-up visits because of geographic inaccessibility
  • Is participating in a competing clinical investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Lombardi Cancer Center

Washington D.C., District of Columbia, 20057, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

UNC Thrombophilia Program

Chapel Hill, North Carolina, 27599-7035, United States

Location

Intermountain Medical Centre

Murray, Utah, 84152, United States

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Health Care Centre

Hamilton, Ontario, L8N 4A6, Canada

Location

Henderson Hospital

Hamilton, Ontario, L8V1C3, Canada

Location

Limerick, Mid Western Regional Hospital

Limerick, Ireland

Location

Addenbrooke's Hospital

Cambridge, B2 0QQ, United Kingdom

Location

Related Publications (3)

  • Kearon C, Parpia S, Spencer FA, Schulman S, Stevens SM, Shah V, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Connors JM, Ginsberg JS, Spadafora L, Julian JA. Long-term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to d-dimer results; A cohort study. J Thromb Haemost. 2019 Jul;17(7):1144-1152. doi: 10.1111/jth.14458. Epub 2019 May 20.

    PMID: 31033194DERIVED

  • Kearon C, Parpia S, Spencer FA, Baglin T, Stevens SM, Bauer KA, Lentz SR, Kessler CM, Douketis JD, Moll S, Kaatz S, Schulman S, Connors JM, Ginsberg JS, Spadafora L, Bhagirath V, Liaw PC, Weitz JI, Julian JA. Antiphospholipid antibodies and recurrent thrombosis after a first unprovoked venous thromboembolism. Blood. 2018 May 10;131(19):2151-2160. doi: 10.1182/blood-2017-09-805689. Epub 2018 Feb 28.

    PMID: 29490924DERIVED

  • Kearon C, Spencer FA, O'Keeffe D, Parpia S, Schulman S, Baglin T, Stevens SM, Kaatz S, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Moll S, Connors JM, Ginsberg JS, Spadafora L, Julian JA; D-dimer Optimal Duration Study Investigators. D-dimer testing to select patients with a first unprovoked venous thromboembolism who can stop anticoagulant therapy: a cohort study. Ann Intern Med. 2015 Jan 6;162(1):27-34. doi: 10.7326/M14-1275.

    PMID: 25560712DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Clive Kearon, MB MRCP(I) FRCP(C) PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 23, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

US(7)GB(1)CA(4)IE(1)