LDE-Paclitaxel for Cardiac Allograft Vasculopathy: A Pilot Study
NCT07929766, Phase 2, Active not recruiting, University of Sao Paulo General Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | LDE-Paclitaxel for Cardiac Allograft Vasculopathy: A Pilot Study | ClinicalTrials.gov |
| NCT number | NCT07929766 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 22 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Sao Paulo General Hospital | ClinicalTrials.gov |
| Conditions | Heart Transplant Recipient, Cardiac Allograft Vasculopathy | ClinicalTrials.gov |
| Interventions | LDE-Paclitaxel, Placebo (LDE) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Feasibility - strict protocol completion | From the first infusion through follow-up angiography/IVUS (approximately 1 month after the 6th infusion; about 5 months) | Proportion of randomized participants who (i) receive all 6 study infusions, each within ±7 days of the scheduled date, AND (ii) undergo follow-up coronary angiography/IVUS within ±14 days of the scheduled date, with at least one vessel with analyzable IVUS at both baseline and follow-up. | ClinicalTrials.gov |
| Primary | Safety - serious or grade ≥3 adverse events related to study drug | From baseline angiography/IVUS through 30 days after the last infusion or 7 days after follow-up angiography/IVUS, whichever is later (about 5 months) | Proportion of participants with at least one adverse event of grade ≥3 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or at least one serious adverse event, considered at least possibly related to the study drug. | ClinicalTrials.gov |
| Secondary | Feasibility - pragmatic protocol completion | From the first infusion through follow-up angiography/IVUS (approximately 1 month after the 6th infusion; about 5 months) | Proportion of randomized participants meeting the strict feasibility criteria, except that a single isolated infusion delay beyond ±7 days is allowed. | ClinicalTrials.gov |
| Secondary | Adverse events by grade, seriousness and relatedness | From baseline angiography/IVUS through 12 months after follow-up angiography/IVUS (about 17 months) | Number of adverse events and proportion of participants with at least one adverse event, classified by CTCAE v5.0 grade, seriousness (serious adverse event criteria) and relatedness to the study drug. | ClinicalTrials.gov |
| Secondary | Treated acute rejection | From baseline angiography/IVUS through 12 months after follow-up angiography/IVUS (about 17 months) | Proportion of participants with acute cellular or antibody-mediated rejection that required treatment, irrespective of relatedness to the study drug. | ClinicalTrials.gov |
| Secondary | Clinically relevant infection | From baseline angiography/IVUS through 12 months after follow-up angiography/IVUS (about 17 months) | Proportion of participants with infection requiring systemic antimicrobial (antibacterial, antifungal or antiviral) therapy and/or hospitalization. | ClinicalTrials.gov |
| Secondary | Change in percent atheroma volume (PAV) | Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months) | Absolute change in PAV (percentage points) from baseline to follow-up IVUS. PAV = 100 × Σ plaque volume / Σ external elastic membrane (EEM) volume, with volumes summed across matched segments of all vessels with analyzable IVUS at both time points. | ClinicalTrials.gov |
| Secondary | Change in normalized total atheroma volume (TAVnorm) | Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months) | Change in TAVnorm (mm³) from baseline to follow-up IVUS. TAVnorm = (Σ plaque area / number of analyzed frames) × median number of analyzed frames in the study population, to adjust for differing analyzed segment lengths. | ClinicalTrials.gov |
| Secondary | Change in maximal intimal thickness (MIT) | Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months) | Change in MIT (mm) from baseline to follow-up IVUS, using for each participant the largest MIT among vessels with analyzable IVUS at both time points. | ClinicalTrials.gov |
| Secondary | Change in minimal lumen area (MLA) | Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months) | Change in MLA (mm²) from baseline to follow-up IVUS, per vessel with analyzable IVUS at both time points. | ClinicalTrials.gov |
| Secondary | Angiographic cardiac allograft vasculopathy grade | Baseline and follow-up angiography (approximately 1 month after the 6th infusion; about 5 months) | CAV grade according to the International Society for Heart and Lung Transplantation (ISHLT) 2010 standardized nomenclature, assessed on coronary angiography at baseline and follow-up. | ClinicalTrials.gov |
| Other | Change in left ventricular ejection fraction (exploratory) | Baseline (closest routine echocardiogram) to follow-up (closest routine echocardiogram to follow-up angiography; about 5 months) | Change in left ventricular ejection fraction (%) between routine clinical transthoracic echocardiograms performed closest to baseline and to follow-up angiography. Echocardiography was not protocol-mandated. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)