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The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olpasiran | Experimental | Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W). |
|
| Placebo | Placebo Comparator | Participants will receive placebo SC Q12W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olpasiran | Drug | Olpasiran will be administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in NCP Volume from Baseline to Week 72 | Baseline to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low Attenuation Plaque Volume from Baseline to Week 72 | Baseline to Week 72 | |
| Change in Total Plaque Volume from Baseline to Week 72 | Baseline to Week 72 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Recruiting | Bridgeport | Connecticut | 06610 | United States | |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| Placebo | Drug | Placebo will be administered SC. |
|
| Change in Calcified Plaque Volume from Baseline to Week 72 |
| Baseline to Week 72 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to Week 74 |
| Jacksonville Center for Clinical Research |
| Recruiting |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Midwest Heart and Vascular Specialists | Recruiting | Overland Park | Kansas | 66211 | United States |
| Flourish Bowie | Recruiting | Bowie | Maryland | 20715 | United States |
| Montefiore Medical Center - Bronx | Recruiting | Philadelphia | Pennsylvania | 19141 | United States |
| Vital Heart and Vein | Recruiting | Humble | Texas | 77338 | United States |
| Advara HeartCare Wesley | Recruiting | Auchenflower | Queensland | 4066 | Australia |
| University of The Sunshine Coast Clinical Trials, Sippy Downs | Recruiting | Sippy Downs | Queensland | 4556 | Australia |
| Advara HeartCare Leabrook | Recruiting | Leabrook | South Australia | 5068 | Australia |
| North York Diagnostic and Cardiac Centre | Recruiting | Vaughan | Ontario | L6A 4N9 | Canada |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210011 | China |
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750004 | China |
| Shaanxi Provincial Peoples Hospital | Recruiting | Xi'an | Shaanxi | 710068 | China |
| Jinan Central Hospital | Recruiting | Jinan | Shandong | 250013 | China |
| Regionshospitalet Gødstrup | Recruiting | Herning | 7400 | Denmark |
| Regionshospitalet Viborg | Recruiting | Viborg | 8800 | Denmark |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur | Recruiting | Nice | 06000 | France |
| Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque | Recruiting | Pessac | 33604 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil | Recruiting | Toulouse | 31059 | France |
| Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau | Recruiting | Tours | 37044 | France |
| Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin | Recruiting | Berlin | 12203 | Germany |
| Universitaetsklinikum Essen | Recruiting | Essen | 45147 | Germany |
| Universitaetsklinikum Frankfurt | Recruiting | Frankfurt am Main | 60590 | Germany |
| Klinikum rechts der Isar der TUM | Recruiting | München | 80636 | Germany |
| Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna | Recruiting | Ferrara | 44124 | Italy |
| IRCCS Centro Cardiologico Monzino | Recruiting | Milan | 20138 | Italy |
| IRCCS Policlinico San Donato | Recruiting | San Donato Milanese | 20097 | Italy |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Recruiting | Torino | 10128 | Italy |
| Tomakomai City Hospital | Recruiting | Tomakomai-shi | Hokkaido | 053-8567 | Japan |
| Osaka Keisatsu Hospital | Recruiting | Osaka | Osaka | 543-0042 | Japan |
| University of Yamanashi Hospital | Recruiting | Chuo-shi | Yamanashi | 409-3898 | Japan |
| Tergooiziekenhuizen, locatie Hilversum | Recruiting | Hilversum | 1201 DA | Netherlands |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | Andalusia | 41009 | Spain |
| Hospital Alvaro Cunqueiro | Recruiting | Vigo | Galicia | 36312 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | 28023 | Spain |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000723009 | olpasiran |
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