Trial · NCT06515678
Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension
NCT06515678, Unknown, Groupe Hospitalier Pitie-Salpetriere
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension. Trials, record NCT06515678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06515678
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension
- NCT number
- NCT06515678
- Status
- Unknown
- Enrollment
- 9,464 participants, actual
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Conditions
- Ovarian Cancer, Antiangiogenic-Associated Hypertension, Adjuvant Bevacizumab, Hypertension
- Interventions
- arm A - angiotensin converting enzyme inhibitors (ACEi), arm B - calcium channel blockers (CCBs), arm R - angiotensin receptor blockers ARB
- First posted
- 2024-07-23
- Last updated
- 2024-07-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival for ovarian cancer | PFS is defined as the time, from ovarian cancer first surgery to death, progression or recurrence, whichever occurres first, assessed up to 7 years | The per-protocol average treatment effect (ATE) will be estimated by the one-, two-, and three-year differences in PFS probability, and three-year restricted mean survival time (RMST) differences in the IPC-weighted population. The main outcome will be at three-year. Covariate adjustment : Covariates included in the inverse probability weighting are: (i) age at trial inclusion, (ii) number and type of comorbidities, (iii) economic deprivation level, (iv) number of general practitioner consultations the year before, (v) number of gynecologist consultation the year before, (vi) number of cardiology consultation at inclusion, (vii) number of nephrology consultation at inclusion, (viii) FIGO stage, (ix) surgical strategy, (x) hospital annual ovarian cancer volume, and (xi) hospital academic status |
| Secondary | Overall survival | OS is defined as the time, from ovarian cancer first surgery to death from any cause, assessed up to 7 years | The per-protocol average treatment effect (ATE) will be estimated by the one-, two-, three-, and five-year differences in OS probability, and five-year restricted mean survival time (RMST) differences in the IPC-weighted population. |
| Secondary | Major Cardiovascular Event (MACE) - narrow definition | Time from ovarian cancer first surgery to the time of MACE-narrow, assessed up to 7 years | MACE-narrow is defined any acute myocardial infarction or cerebrovascular infarction. A competing risk model will be used for the occurrence of MACE narrow and broad, with death as a competing event. The investigators will utilize time-varying inverse probability of censoring weights (IPCW). The first step of the IPCW method consists in censoring patients who died. The death censoring mechanism may depend on the baseline and time-dependent factors. The IPCW method introduces weights to correct for this dependent censoring. The second step of the IPCW method is thus to use inverse probability of censoring weights with baseline covariates and time-dependent covariates : (i) Number of cardiology consultations, (ii) Number of nephrology consultations. MACE will be analyzed up to 36 months to assess the direct impact of bevacizumab use. Longer-term outcomes will be available in the supplemental only. |
| Secondary | Major Cardiovascular Event (MACE) - broad definition | Time from ovarian cancer first surgery to the time of MACE-broad, assessed up to 7 years | MACE-narrow is defined any acute myocardial infarction or cerebrovascular infarction. A competing risk model will be used for the occurrence of MACE narrow and broad, with death as a competing event. The investigators will utilize time-varying inverse probability of censoring weights (IPCW). The first step of the IPCW method consists in censoring patients who died. The death censoring mechanism may depend on the baseline and time-dependent factors. The IPCW method introduces weights to correct for this dependent censoring. The second step of the IPCW method is thus to use inverse probability of censoring weights with baseline covariates and time-dependent covariates : (i) Number of cardiology consultations, (ii) Number of nephrology consultations. MACE will be analyzed up to 36 months to assess the direct impact of bevacizumab use. Longer-term outcomes will be available in the supplemental only. |
| Secondary | Time to treatment failure (TTF) | Time from bevacizumab initiation to the first antihypertensive treatment switch or change to bitherapy, assessed up to 7 years | Treatment failure is defined as the necessity to switch antihypertensive therapy, add a new antihypertensive therapy (bitherapy), the occurrence of a MACE-broad, recurrence or death. Time to antihypertensive treatment failure (TTF) will be assessed by the median TTF in each study arm (CCBs and ACEi). Dose increase was not considered a treatment failure. TTF is censored at bevacizumab withdrawal. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40999916 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06515678
GET https://conductscience.org/api/trials/v1/NCT06515678/registered