NCT04757766: VAP-PRO-C6

VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)

Completed Results posted Last updated 19 September 2024

What this trial tests

trial testing in daily everyday routine practice in Chronic Venous Insufficiency in 350 participants. Completed in 31 May 2022.

Timeline

1 March 2021

Primary endpoint
31 May 2022

31 May 2022

Quick facts

Lead sponsor	Servier Russia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	350
Start date	1 March 2021
Primary completion	31 May 2022
Estimated completion	31 May 2022
Sites	1 location across Russia

Drugs / interventions tested

• in daily everyday routine practice — full drug profile →

Conditions studied

• Chronic Venous Insufficiency — all drugs for Chronic Venous Insufficiency →

Sponsor

Servier Russia — full company profile →

Who can join

18 and older, any sex, with Chronic Venous Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy Primary · 6 months

% of patients with complete healing of the reference venous ulcer after 6 months

Group	Value	95% CI
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice	243

Eeffectiveness of Systemic Pharmacotherapy Primary · 6 months

% of patients with reduction in the CVD clinical class by CEAP classification

Group	Value	95% CI
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice	247

Healing of the Reference Venous Ulcers #1 Secondary · 3 months

% of patients with healed reference VU after 3 months of treatment

Group	Value	95% CI
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice	47

Healing of the Reference Venous Ulcers at Visit 3 vs Baseline Secondary · 6 months

change in the area of reference VU in cm² (measured with LesionMeter application)

Group	Value	95% CI
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice	8.02	± 4.06

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0.29%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice

Serious: 0/349 (0%)

Deaths: 0/349

Other adverse events (1 terms — click to expand)

Reaction	System	Patients With Venous Ulcer…
exacerbation of chronic gastritis	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04757766 adverse events section.

Sponsor's own description

The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6. This program is planned to be carried out in Russia in 2021-2022.

Publications & conference data

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