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TerminatedNCT01894204PADIS-HTPUpdated Jul 20, 2018

Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.

An interventional study of HTPPE in HTPPE and Idiopathic Pulmonary Embolism, sponsored by University Hospital, Brest. Terminated at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-20.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Diagnostic

Why this study was terminated
The maximum of inclusions was reached
Phase
Not applicable
Study type
Interventional
Enrollment
235
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.

02

Conditions studied

  • HTPPE
  • Idiopathic Pulmonary Embolism

Keywords

  • HTTPE
  • Idiopathic Pulmonary embolism
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In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's enrollment of 235 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.

Exclusion criteria

Exclusion Criteria:

  • Refusal to grant in writing to participate in the study PADIS HTP
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
235 participants (actual)

Study arms

  • Other
    HTPPE

    No drug and no placebo were used in this study. For all the patients who participated at the study PADIS-EP, somme exams must be performed.

    Other: HTPPE

Interventions

  • OtherHTPPE

    No drug and no placebo were used in this study. Some exams must be performed (DLCO - evaluation of the dyspnoea and pulmonary scintigraphy), and in function of the result of the pulmonary scintigraphy, the medical care of the patient will be different : negative pulmonary scintigraphy, stop of the explorations and taken care usual of the patients; positive pulmonary scintigraphy,realisation of a cardiac echography to estimate the presence or not of a not very probable, possible or likely HTP. The indication of the right cardiac catheterization is then put on the combination of the results of the cardiac echography and the evaluation of the dyspnoea.

06

What researchers measure

Primary outcomes

  1. Frequency of a HTPPE

    Time frame: 24 months

Secondary outcomes

  1. Mortality and cause

    Time frame: 24 months

07

Study locations

8 sites
  • CHRU de Brest
    Brest, 29609, France
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
  • CH de Lannion
    Lannion, 22300, France
  • Hôpital Européen Georges Pompidou
    Paris cedex 15, 75908, France
  • CHU Pontchaillou - Hôpital Sud
    Rennes, 35056, France
  • Hôpital Yves Le Foll
    Saint-Brieuc, 22027, France
  • Hôpital de Bellevue - CHU de Saint-Etienne
    Saint-Etienne, 45055, France
  • Hôpital Rangueuil
    Toulouse, 31059, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01894204
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jul 10, 2013
Start date
Jun 27, 2013
Primary completion
May 29, 2018
Completion
May 29, 2018
Last update
Jul 20, 2018

Study contacts

Francis COUTURAUD, PU-PH
principal investigator · CHRU de Brest

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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