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Alirocumab and Plaque Burden In Familial Hypercholesterolaemia (ARCHITECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05465278
Recruitment Status : Completed
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Fundación Hipercolesterolemia Familiar

Brief Summary:
Low-level, open-label, multicenter clinical trial to evaluate the effect of alirocumab on the volume, architecture and composition of atherosclerotic plaque in patients with Familial hypercholesterolemia from the SAFEHEART Registry. ARCHITECT study

Condition or disease Intervention/treatment Phase
Familial Hypercholesterolemia Drug: Alirocumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Low-intervention, open-label, multicenter, phase IV clinical trial to evaluate the effect 18 months after initiation of alirocumab (Praluent®) on the volume, architecture, and composition of the coronary atheroma plaque in subjects with FH and without clinical cardiovascular disease followed in the SAFEHEART registry in optimized and stable treatment with maximum tolerated doses of statins with or without other lipid-lowering treatments under clinical practice conditions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Effect of Alirocumab on the Volume, Architecture and Composition of Atherosclerotic Plaque in Patients With Familial Hypercholesterolemia
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 30, 2022
Actual Study Completion Date : March 30, 2022


Arm Intervention/treatment
Experimental: Alirocumab
Every patient enrolled witll receive treatment witl Alirocumab
Drug: Alirocumab
18 months treatment with alirocumab




Primary Outcome Measures :
  1. Change in atherosclerotic plaque burden (%) assessed by coronary computed tomography [ Time Frame: 18 months ]
    change in plaque burden assessed by coronary computed tomography at enrollemnt and at follow-up. Coronary plaque burden and its cgaracteristics will be analysed ant enrollment and at the end of the follow-up


Secondary Outcome Measures :
  1. Changue in plaque volume (mm3) assessed by coronary computed tomography [ Time Frame: 18 months ]
    Change in plaque volume assessed by coronary computed tomography at enrollement and at follow up. Coronary plaque volume will be analysed ant enrollment and at the end of the follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have voluntarily granted informed consent (preferably in writing or, failing that, orally before independent witnesses of the research team) before carrying out the specific procedures of the trial.
  • Patients of both sexes aged between 35 and 65 years.
  • Patients with a molecular diagnosis of heterozygous HF included in the Spanish SAFEHEART registry (http://safeheart.colesterolfamiliar.org/).
  • Asymptomatic patients.
  • Patients without a previous history of clinical cardiovascular events (acute myocardial infarction [AMI], stroke, coronary revascularization, etc.).
  • Patients on optimized and stable treatment with maximum tolerated doses of a statin with or without other lipid-lowering therapies, for at least 3 months, with inadequate control, defined by a LDL-C level> 100 mg / dL.
  • Availability of a coronary CTA performed in the 3 months prior to the baseline visit. If a coronary CTA is not available, this test will be performed during the selection period.
  • ATC of at least 64 cuts performed in a center with sufficient experience (more than 100 ACTs per year).
  • Patients with a PVA> 30% in the baseline coronary CTA, performed in the last 3 months before the baseline visit.
  • Patients in whom treatment with alirocumab 150 mg / mL is indicated, according to the characteristics of the patient and the Praluent® technical data sheet.

Exclusion Criteria:

  • Class> II heart failure according to the functional classification of the NYHA scale (New York Heart Association).
  • Heart rate different from normal sinus rhythm (regular HR between 60-100 bpm).
  • Previous history of AMI, angina, peripheral arterial thrombosis, stroke or transient ischemic attack (TIA).
  • Uncontrolled hypertension defined as a resting systolic blood pressure value> 180 mmHg at the baseline visit.
  • Fasting triglyceride levels> 250 mg / dl at baseline visit.
  • Type 1 diabetes or insufficiently controlled type 2 diabetes (HbA1> 9%).
  • Personal or family history of inherited muscle disorders.
  • Known thyroid disease or thyroid replacement therapy.
  • Glomerular filtration rate <60 ml / min / 1.73 m2 at baseline visit.
  • Elevated ALT and / or AST levels (> 3 times the ULN at the baseline visit).
  • Elevated creatinine kinase levels (> 3 times ULN at baseline).
  • Patients who have previously received iPCSK9, CETP (cholesterol ester transport protein) inhibitors, mipomersen and / or lomitapide.
  • Patients with statin intolerance.
  • Active cancer or previous history of cancer.
  • Clinically relevant active infection or clinically significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction.
  • Availability of a baseline coronary ACT that does not meet the technical requirements for the images to be adequately processed using the QAngio CT software.
  • Patient being treated with any investigational drug / product or participating in a clinical trial using an investigational product, with the exception of studies in which the study treatment has been completed more than 6 months ago.
  • Pregnant or breast-feeding women, and sexually active women of childbearing potential who are unwilling to use an adequate contraceptive method (such as oral contraceptives, intrauterine device, or barrier method of contraception along with spermicide or surgical sterilization) during the study. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05465278


Locations
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Spain
Fundacion Hipercolesterolemia Familiar
Madrid, Spain, 28010
Sponsors and Collaborators
Fundación Hipercolesterolemia Familiar
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Responsible Party: Fundación Hipercolesterolemia Familiar
ClinicalTrials.gov Identifier: NCT05465278    
Other Study ID Numbers: ARCHITECT
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias