Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
The objective of the study is to determine the proportion of Atherosclerotic cardiovascular disease (ASCVD) and/or Heterozygous Familial Hypercholesterolemia (HeFH) patients reaching low-density lipoprotein-cholesterol (LDL-C) goals according to their cardiovascular risk at 12 months after the initiation of inclisiran treatment.
The study also aims to evaluate changes in LDL-C levels, safety profile, adherence and persistence to inclisiran treatment, use of concomitant lipid-lowering therapy (LLT), and patient satisfaction with inclisiran among other variables collected in clinical practice.
This is a non-interventional, prospective, multicentric, and nationwide study that will be conducted in routine clinical practice in Spain. This study will consist of three visits, coinciding with those conducted as part of the patients' routine follow-up, without interfering with the clinical practice of the participating centers. A blood test to assess LDL-C levels will be conducted at 3, 6, 9 and 12 months after inclisiran initiation, according to clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran | Adults (≥18 years) with a confirmed clinical indication for inclisiran. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclisiran | Other | This is an observational study, there is no treatment allocation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C levels - 12 months | Proportion of participants reaching guideline-established low densitiy lipoprotein-Cholesterol (LDL-C) targets according to their Cardiovascular (CV) risk
| 12 months following the initiation of inclisiran treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-C levels - 6 months | Proportion of participants reaching guideline-established LDL-C targets according to their CV risk
| 6 months following the initiation of inclisiran treatment |
| non-HLDL-C levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Participating in a clinical trial of a treatment that could modify LDL-C levels during the observational period of the study.
Not provided
Not provided
Adults (≥18 years) with a confirmed clinical indication for inclisiran.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Cadiz | Andalusia | 11009 | Spain | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No samples will be retained.
Proportion of participants with hypertriglyceridemia (triglycerides >400 mg/dL) reaching guideline-established non-HDL-C targets according to their CV risk
|
| 6 and 12 months following the initiation of inclisiran treatment |
| Changes from baseline in LDL-C | Change from baseline to mean LDL-C in PCSK9i naïve patients and patients pre-treated with PCSK9i, separately. | Baseline, 3, 6, 9 and 12 months following the initiation of inclisiran treatment |
| Frequency of AEs | Incidence of AEs including, number of cardiovascular events, revascularizations, emergency visits, and hospitalizations qualifying and reported as AEs. | From inclisiran initiation up to 12 months post-initiation |
| Adherence rate to the concomitant LLT treatment | Number of participants with a Morisky Medication Adjerence Slace (MMAS) of over 80%To describe the utilization and adherence to concomitant LLT during inclisiran treatment. | From 1st visit up to 12 months after inclisiran initiation |
| Proportion of participants adhering to the prescribed inclisiran dosing schedule | To evaluate treatment adherence to inclisiran during the study period. | From 1st visit up to 12 months after inclisiran initiation |
| Inclisiran reasons for non-persistence | Number of participants by reasons for non- persistence | From 1st visit up to 12 months after inclisiran initiation |
| Lp(a) | Proportion of participants with Lp(a) ≥50 mg/dL (≥125 nmol/L), ≥70 mg/dL (≥175 nmol/L), ≥90 mg/dL (≥225 nmol/L). | When available, from baseline up to 12 months after inclisiran initiation |
| Changes in Lp(a) | To describe changes in Lp(a) at any time after inclisiran treatment, only in patients tested by clinical judgment. | From inclisiran initiation up to 12 months post-initiation |
| Patient satisfaction with inclisiran, score on TSQM-II | Treatment Satisfaction Questionnaire for Medication II evaluates satisfaction with treatment effectiveness, side effects, convenience, and global satisfaction. The TSQM-II consists of 11 items, each with 7 response options. Scores for each domain are calculated by averaging responses, transformed to a 0-100 scale, where higher scores indicate greater satisfaction | 3 and at 12 months after treatment initiation. |
| Specialty of the health care profesional prescribing inclisiran | To describe prescribing specialty. | From 1st visit up to 12 months after inclisiran initiation |
| HCP who administers inclisiran | To describe, HCP that administer inclisiran | From 1st visit up to 12 months after inclisiran initiation |
| Site of treatment administration for each dose | To describe site of treatment administration (primary, secondary or tertiary hospital, primary care center) | From 1st visit up to 12 months after inclisiran initiation |
| Granada |
| Andalusia |
| 18014 |
| Spain |
| Novartis Investigative Site | Huelva | Andalusia | 21005 | Spain |
| Novartis Investigative Site | Jaén | Andalusia | 23007 | Spain |
| Novartis Investigative Site | Marbella | Andalusia | 29600 | Spain |
| Novartis Investigative Site | Mallorca | Balearic Islands | 07198 | Spain |
| Novartis Investigative Site | Puerto Real | Cadiz | 11510 | Spain |
| Novartis Investigative Site | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Andújar | Jaen | 23740 | Spain |
| Novartis Investigative Site | Logroño | La Rioja | 26006 | Spain |
| Novartis Investigative Site | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Novartis Investigative Site | Burgos | 09006 | Spain |
| Novartis Investigative Site | Córdoba | 14004 | Spain |
| Novartis Investigative Site | Fuerteventura | 35600 | Spain |
| Novartis Investigative Site | Las Palmas GC | 35010 | Spain |
| Novartis Investigative Site | Málaga | 29010 | Spain |
| Novartis Investigative Site | Salamanca | 37007 | Spain |
| Novartis Investigative Site | Seville | 41009 | Spain |
| Novartis Investigative Site | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C585830 | ALN-PCS |
Not provided
Not provided
Not provided