Six Years of Follow-up After Idiopathic Venous Throbmoembolism (Padis-Ext)
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ClinicalTrials.gov Identifier: NCT02884934 |
Recruitment Status :
Recruiting
First Posted : August 31, 2016
Last Update Posted : February 22, 2019
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Condition or disease |
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Pulmonary Embolism Proximal Deep Vein Thrombosis |
Study Type : | Observational |
Estimated Enrollment : | 748 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Six Years of Follow-up After Extended Duration of Oral Anticoagulant Therapy for a First Episode of Idiopathic Pulmonary Embolism or Proximal Deep Vein Thrombosis. |
Actual Study Start Date : | March 28, 2013 |
Estimated Primary Completion Date : | November 2022 |
Estimated Study Completion Date : | November 2022 |

- Symptomatic recurrent venous thromboembolism [ Time Frame: 6 years ]
- Major Bleeding [ Time Frame: 6 years ]
- Chronic Thromboembolic Pulmonary Hypertension [ Time Frame: 6 years ]
- Post-Thrombotic Syndrome [ Time Frame: 6 years ]

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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: | Probability Sample |
Inclusion Criteria:
- Patients with a first episode of idiopathic pulmonary embolism or idiopathic proximal deep vein thrombosis who have been initially treated during 6 months or 24 months using Vitamin K antagonist with a INR between 2 and 3 and enrolled in clinical study Padis-Ep and Padis TVP
Exclusion Criteria:
Participation refused

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): NCT02884934
Contact: Francis COUTURAUD | francis.couturaud@chu-brest.fr |
France | |
CHRU de Brest | Recruiting |
Brest, France, 29609 | |
Contact: Francis Couturaud | |
CHU de Clermont-Ferrand | Recruiting |
Clermont-Ferrand, France | |
Contact: Jeannot Schmidt | |
CHU de Grenoble | Recruiting |
Grenoble, France, 38043 | |
Contact: Gilles Pernod | |
CH de Lannion | Recruiting |
Lannion, France | |
Contact: Karine Provost | |
CH de Lorient | Recruiting |
Lorient, France | |
Contact: Serge Baleynaud | |
CHU de Nantes | Recruiting |
Nantes, France, 44093 | |
Contact: Pierre Pottier | |
Hôpital Européen Georges Pompidou | Recruiting |
Paris, France, 75015 | |
Contact: Guy Meyer | |
AP-HP Kremlin Bicetre | Recruiting |
Paris, France | |
Contact: Florence Parent | |
Hotel Dieu | Recruiting |
Paris, France | |
Contact: Christine Lorut | |
CHIC Quimper | Recruiting |
Quimper, France | |
Contact: Rémy Brenard | |
CHU de Rennes | Recruiting |
Rennes, France, 35023 | |
Contact: Patrick Jego | |
CH St Brieuc | Recruiting |
St Brieuc, France | |
Contact: Duhamel | |
CHU de St Etienne | Recruiting |
St Etienne, France | |
Contact: Patrick Mismetti | |
CHU de Toulouse | Recruiting |
Toulouse, France | |
Contact: Alexandra Bura-Riviere | |
CHU de Tours | Recruiting |
Tours, France, 37000 | |
Contact: Yves GRUEL |
Study Director: | Francis COUTURAUD | CHRU de Brest |
Responsible Party: | University Hospital, Brest |
ClinicalTrials.gov Identifier: | NCT02884934 |
Other Study ID Numbers: |
Padis-Extension (RB 12.075) |
First Posted: | August 31, 2016 Key Record Dates |
Last Update Posted: | February 22, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
venous thromboembolism recurrent venous thromboembolism anticoagulant-related bleeding |
Pulmonary Embolism Thrombosis Embolism Venous Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |