NCT03054727 (SPOT) is a clinical trial of Villalta phone score > or = to 5 in Post Thrombotic Syndrome, sponsored by Association des Médecins Vasculaires Hospitaliers.

Who is sponsoring NCT03054727?

NCT03054727 is sponsored by Association des Médecins Vasculaires Hospitaliers.

What drugs are being tested in NCT03054727?

Interventions in NCT03054727: Villalta phone score > or = to 5, Villalta phone score < 5.

What condition does NCT03054727 study?

NCT03054727 studies Post Thrombotic Syndrome, Venous Thromboembolism, Cardiovascular Diseases.

Is NCT03054727 still recruiting?

NCT03054727 is currently completed. Last updated 23 January 2023.

Last reviewed 2023-01-23 · How we verify

NCT03054727: SPOT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long Term Assessment of Post Thrombotic Syndrome : OPTIMEV Study ( SPOT )

Completed Last updated 23 January 2023

What this trial tests

trial testing Villalta phone score > or = to 5 in Post Thrombotic Syndrome in 2,475 participants. Completed in 31 December 2022.

Timeline

11 July 2017

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Association des Médecins Vasculaires Hospitaliers
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,475
Start date	11 July 2017
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across France

Drugs / interventions tested

Villalta phone score > or = to 5
Villalta phone score < 5

Conditions studied

Post Thrombotic Syndrome — all drugs for Post Thrombotic Syndrome →
Venous Thromboembolism — all drugs for Venous Thromboembolism →
Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Association des Médecins Vasculaires Hospitaliers

Who can join

18 and older, any sex, with Post Thrombotic Syndrome or Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Post-thrombotic syndrome (PTS) is a frequent and burdensome complication of deep-vein thrombosis (DVT). In the absence of curative treatment of established PTS, its management is based on the prevention of its occurrence thanks to anticoagulants and compression stockings. So far, predictors of disabling PTS are unknown precluding from optimally selecting patients for invasive (early thrombus removal) or innovative/expensive treatments. In addition, little is known on the incidence of PTS in the very long-term. Objectives: To assess, 12 years after a symptomatic venous thromboembolic (VTE) event, Primary objective: incidence and severity of PTS after a lower limb DVT. Main Secondary objectives: 1. Incidence and severity of PTS according to VTE initial presentation (isolated distal DVT, isolated proximal DVT, PE + DVT). 2. Incidence and risk factors of disabling PTS Methods: Very long-term follow-up (12 years) of patients recruited in the large, multicentre, prospective, observational OPTIMEV study for a suspicion of VTE confirmed or ruled out with objective tests (Clinical Trials NCT00670540). All patients with a DVT, an isolated PE and a random selection of controls (VTE - patients without any history of VTE after the 3 years of follow-up) will first benefit from a phone-PTS assessment. Those patients presenting at least a mild venous insufficiency and a selection of controls will undergo a clinical follow-up visit with clinical and Compleat Ultra Sound (CUS) assessment of PTS/venous insufficiency and an assessment of quality of life. Perspectives: Improving our knowledge of PTS' incidence and predictors and of the impact of usual treatment. Better selecting patients eligible for invasive/innovative/expensive preventative procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03054727 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Association des Médecins Vasculaires Hospitaliers
Last refreshed: 23 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03054727.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing