Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519917-72-00 | EU Trial (CTIS) Number |
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
The purpose of this study is to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo administered subcutaneously (SC) once every 6 months (q6M) during the double-blind (DB) period, followed by nucresiran 300 mg administered SC q6M during the open-label extension (OLE) period. |
|
| Nucresiran 300 mg | Experimental | Participants will receive nucresiran 300 mg administered SC Q6M during the DB period, followed by nucresiran 300 mg administered SC q6M during the OLE period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucresiran | Drug | Nucresiran 300 mg administered SC q6M |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of all-cause mortality and recurrent cardiovascular [CV] events (CV hospitalizations and urgent heart failure [HF] visits) | All-cause mortality and recurrent CV events (CV hospitalizations and urgent HF visits) will be compared between treatment groups using an Andersen-Gill model. | Baseline to end of double-blind period (estimated 32 months, maximum 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first CV event (CV hospitalizations and urgent HF visits) or all-cause mortality | Baseline to end of double-blind period (estimated 32 months, maximum 5 years) | |
| All-cause mortality | Baseline to end of double-blind period (estimated 32 months, maximum 5 years) |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information Line | Contact | 1-877-ALNYLAM | clinicaltrials@alnylam.com | |
| Clinical Trial Information Line | Contact | 1-877-256-9526 | clinicaltrials@alnylam.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Recruiting | La Jolla | California | 92037 | United States | |
| Clinical Trial Site |
Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.
Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, a planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more.
Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sterile Normal Saline (0.9% NaCl) | Drug | Sterile Normal Saline (0.9% NaCl) administered SC once q6M |
|
| Recurrent CV events (CV hospitalizations and urgent HF visits) | Baseline to end of double-blind period (estimated 32 months, maximum 5 years) |
| Change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) | The KCCQ is a 23-item self-administered questionnaire quantifying 6 domains (symptoms, physical function, quality of life, social limitation, self-efficacy, and symptom stability) and 2 summary scores (clinical and overall summary [OS]). Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | Baseline to Month 30 |
| Recruiting |
| Stanford |
| California |
| 94305 |
| United States |
| Clinical Trial Site | Recruiting | Norwich | Connecticut | 06360 | United States |
| Clinical Trial Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Clinical Trial Site | Recruiting | Brandon | Florida | 33511 | United States |
| Clinical Trial Site | Recruiting | Miami | Florida | 33125 | United States |
| Clinical Trial Site | Recruiting | Atlanta | Georgia | 30309 | United States |
| Clinical Trial Site | Recruiting | Gainesville | Georgia | 30501 | United States |
| Clinical Trial Site | Recruiting | Tucker | Georgia | 30084 | United States |
| Clinical Trial Site | Recruiting | Evanston | Illinois | 60201 | United States |
| Clinical Trial Site | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Clinical Trial Site | Recruiting | Indianapolis | Indiana | 46260 | United States |
| Clinical Trial Site | Recruiting | Kansas City | Kansas | 66160 | United States |
| Clinical Trial Site | Recruiting | Baltimore | Maryland | 21287 | United States |
| Clinical Trial Site | Recruiting | Boston | Massachusetts | 02115 | United States |
| Clinical Trial Site | Recruiting | Boston | Massachusetts | 02118 | United States |
| Clinical Trial Site | Recruiting | Detroit | Michigan | 48202 | United States |
| Clinical Trial Site | Recruiting | Rochester | Minnesota | 55905 | United States |
| Clinical Trial Site | Recruiting | St Louis | Missouri | 63110 | United States |
| Clinical Trial Site | Recruiting | Manhasset | New York | 11030 | United States |
| Clinical Trial Site | Recruiting | New York | New York | 10029 | United States |
| Clinical Trial Site | Recruiting | New York | New York | 10032 | United States |
| Clinical Trial Site | Recruiting | New York | New York | 10065 | United States |
| Clinical Trial Site | Recruiting | The Bronx | New York | 10467 | United States |
| Clinical Trial Site | Recruiting | Charlotte | North Carolina | 28204 | United States |
| Clinical Trial Site | Recruiting | Cleveland | Ohio | 44195 | United States |
| Clinical Trial Site | Recruiting | Portland | Oregon | 97239 | United States |
| Clinical Trial Site | Recruiting | Lancaster | Pennsylvania | 17602 | United States |
| Clinical Trial Site | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Trial Site | Recruiting | Charleston | South Carolina | 29425 | United States |
| Clinical Trial Site | Recruiting | Dallas | Texas | 75246 | United States |
| Clinical Trial Site | Recruiting | Houston | Texas | 77030 | United States |
| Clinical Trial Site | Recruiting | Plano | Texas | 75024 | United States |
| Clinical Trial Site | Recruiting | Salt Lake City | Utah | 84132 | United States |
| Clinical Trial Site | Recruiting | Charlottesville | Virginia | 22903 | United States |
| Clinical Trial Site | Recruiting | Falls Church | Virginia | 22042 | United States |
| Clinical Trial Site | Recruiting | Norfolk | Virginia | 23507 | United States |
| Clinical Trial Site | Recruiting | Richmond | Virginia | 23298 | United States |
| Clinical Trial Site | Recruiting | Spokane | Washington | 99204 | United States |
| Clinical Trial Site | Recruiting | Buenos Aires | C1025ABI | Argentina |
| Clinical Trial Site | Recruiting | Buenos Aires | C1093AAS | Argentina |
| Clinical Trial Site | Recruiting | Buenos Aires | C1199ABB | Argentina |
| Clinical Trial Site | Recruiting | Buenos Aires | C1428 | Argentina |
| Clinical Trial Site | Recruiting | Rosario | S2000DEJ | Argentina |
| Clinical Trial Site | Recruiting | Rosario | S2000DSR | Argentina |
| Clinical Trial Site | Recruiting | Rosario | S2000GAP | Argentina |
| Clinical Trial Site | Recruiting | Adelaide | 5000 | Australia |
| Clinical Trial Site | Recruiting | Bedford Park | 5042 | Australia |
| Clinical Trial Site | Recruiting | Box Hill | 3128 | Australia |
| Clinical Trial Site | Recruiting | Chermside | 4032 | Australia |
| Clinical Trial Site | Recruiting | Darlinghurst | 2010 | Australia |
| Clinical Trial Site | Recruiting | Joondalup | 6027 | Australia |
| Clinical Trial Site | Recruiting | Liverpool | 2170 | Australia |
| Clinical Trial Site | Recruiting | Westmead | 2145 | Australia |
| Clinical Trial Site | Recruiting | Braunau am Inn | 5280 | Austria |
| Clinical Trial Site | Recruiting | Graz | 8036 | Austria |
| Clinical Trial Site | Recruiting | Vienna | 1090 | Austria |
| Clinical Trial Site | Recruiting | Vienna | 1100 | Austria |
| Clinical Trial Site | Recruiting | Vienna | 1160 | Austria |
| Clinical Trial Site | Recruiting | Vienna | 1210 | Austria |
| Clinical Trial Site | Recruiting | Wels | 4600 | Austria |
| Clinical Trial Site | Recruiting | Aalst | 9300 | Belgium |
| Clinical Trial Site | Recruiting | Bruges | 8000 | Belgium |
| Clinical Trial Site | Recruiting | Brussels | 1200 | Belgium |
| Clinical Trial Site | Recruiting | Dendermonde | 9200 | Belgium |
| Clinical Trial Site | Recruiting | Genk | 3600 | Belgium |
| Clinical Trial Site | Recruiting | Ghent | 9000 | Belgium |
| Clinical Trial Site | Recruiting | Hasselt | 3500 | Belgium |
| Clinical Trial Site | Recruiting | Leuven | 3000 | Belgium |
| Clinical Trial Site | Recruiting | Liège | 4000 | Belgium |
| Clinical Trial Site | Recruiting | Roeselare | 8800 | Belgium |
| Clinical Trial Site | Recruiting | Belo Horizonte | 30220-140 | Brazil |
| Clinical Trial Site | Recruiting | Porto Alegre | 90035-903 | Brazil |
| Clinical Trial Site | Recruiting | Porto Alegre | 90560-032 | Brazil |
| Clinical Trial Site | Recruiting | Ribeirão Preto | 14026-900 | Brazil |
| Clinical Trial Site | Recruiting | Ribeirão Preto | 14051-140 | Brazil |
| Clinical Trial Site | Recruiting | Rio de Janeiro | 20551-030 | Brazil |
| Clinical Trial Site | Recruiting | Salvador | 40170-130 | Brazil |
| Clinical Trial Site | Recruiting | São Paulo | 04038-002 | Brazil |
| Clinical Trial Site | Recruiting | São Paulo | 05403-000 | Brazil |
| Clinical Trial Site | Recruiting | Calgary | T2N 4N1 | Canada |
| Clinical Trial Site | Recruiting | London | N6A 5A5 | Canada |
| Clinical Trial Site | Recruiting | Vancouver | V6Z 1Y6 | Canada |
| Clinical Trial Site | Recruiting | Santiago | 7500588 | Chile |
| Clinical Trial Site | Recruiting | Santiago | 8320000 | Chile |
| Clinical Trial Site | Recruiting | Dongcheng | 100006 | China |
| Clinical Trial Site | Recruiting | Haidian | 100191 | China |
| Clinical Trial Site | Recruiting | Hangzhou | 310009 | China |
| Clinical Trial Site | Recruiting | Brno | 602 00 | Czechia |
| Clinical Trial Site | Recruiting | Ostrava | 708-52 | Czechia |
| Clinical Trial Site | Recruiting | Prague | 128 21 | Czechia |
| Clinical Trial Site | Recruiting | Prague | 140 21 | Czechia |
| Clinical Trial Site | Recruiting | Aarhus N | 8200 | Denmark |
| Clinical Trial Site | Recruiting | København Ø | 2100 | Denmark |
| Clinical Trial Site | Recruiting | Odense C | 5000 | Denmark |
| Clinical Trial Site | Recruiting | Chambray-lès-Tours | 37170 | France |
| Clinical Trial Site | Recruiting | Créteil | 94000 | France |
| Clinical Trial Site | Recruiting | Dijon | 21000 | France |
| Clinical Trial Site | Recruiting | La Tronche | 38700 | France |
| Clinical Trial Site | Recruiting | Marseille | 13005 | France |
| Clinical Trial Site | Recruiting | Martinique | 97261 | France |
| Clinical Trial Site | Recruiting | Montpellier | 34295 | France |
| Clinical Trial Site | Recruiting | Paris | 75015 | France |
| Clinical Trial Site | Recruiting | Paris | 75018 | France |
| Clinical Trial Site | Recruiting | Pessac | 33600 | France |
| Clinical Trial Site | Recruiting | Reims | 51100 | France |
| Clinical Trial Site | Recruiting | Rennes | 35000 | France |
| Clinical Trial Site | Recruiting | Rouen | 76031 | France |
| Clinical Trial Site | Recruiting | Saint-Herblain | 44093 | France |
| Clinical Trial Site | Recruiting | Strasbourg | 67091 | France |
| Clinical Trial Site | Recruiting | Toulouse | 31059 | France |
| Clinical Trial Site | Recruiting | Berlin | 13353 | Germany |
| Clinical Trial Site | Recruiting | Cologne | 50937 | Germany |
| Clinical Trial Site | Recruiting | Göttingen | 37075 | Germany |
| Clinical Trial Site | Recruiting | Hanover | 30625 | Germany |
| Clinical Trial Site | Recruiting | Heidelberg | 69120 | Germany |
| Clinical Trial Site | Recruiting | Leipzig | 04103 | Germany |
| Clinical Trial Site | Recruiting | Magdeburg | 39120 | Germany |
| Clinical Trial Site | Recruiting | Munich | 81377 | Germany |
| Clinical Trial Site | Recruiting | Münster | 48149 | Germany |
| Clinical Trial Site | Recruiting | Würzburg | 97080 | Germany |
| Clinical Trial Site | Recruiting | Athens | 115 27 | Greece |
| Clinical Trial Site | Recruiting | Athens | 115 28 | Greece |
| Clinical Trial Site | Recruiting | Heraklion | 714 09 | Greece |
| Clinical Trial Site | Recruiting | Thessaloniki | 546 36 | Greece |
| Clinical Trial Site | Recruiting | Hong Kong | 999077 | Hong Kong |
| Clinical Trial Site | Recruiting | Balatonfüred | 8230 | Hungary |
| Clinical Trial Site | Recruiting | Budapest | 1085 | Hungary |
| Clinical Trial Site | Recruiting | Dublin | D07 R2WY | Ireland |
| Clinical Trial Site | Recruiting | Dublin | D08 NHY1 | Ireland |
| Clinical Trial Site | Recruiting | Be’er Ya‘aqov | 70300 | Israel |
| Clinical Trial Site | Recruiting | Haifa | 3109601 | Israel |
| Clinical Trial Site | Recruiting | Jerusalem | 91120 | Israel |
| Clinical Trial Site | Recruiting | Petah Tikva | 4941492 | Israel |
| Clinical Trial Site | Recruiting | Ancona | 60126 | Italy |
| Clinical Trial Site | Recruiting | Bologna | 40138 | Italy |
| Clinical Trial Site | Recruiting | Brescia | 25123 | Italy |
| Clinical Trial Site | Recruiting | Florence | 50134 | Italy |
| Clinical Trial Site | Recruiting | Forlì | 47121 | Italy |
| Clinical Trial Site | Recruiting | Lecce | 73100 | Italy |
| Clinical Trial Site | Recruiting | Milan | 20122 | Italy |
| Clinical Trial Site | Recruiting | Naples | 80131 | Italy |
| Clinical Trial Site | Recruiting | Padova | 35128 | Italy |
| Clinical Trial Site | Recruiting | Pavia | 27100 | Italy |
| Clinical Trial Site | Recruiting | Pisa | 56124 | Italy |
| Clinical Trial Site | Recruiting | Rimini | 47923 | Italy |
| Clinical Trial Site | Recruiting | Roma | 00168 | Italy |
| Clinical Trial Site | Recruiting | Rome | 00161 | Italy |
| Clinical Trial Site | Recruiting | Torino | 10126 | Italy |
| Clinical Trial Site | Recruiting | Bunkyō City | 113-8655 | Japan |
| Clinical Trial Site | Recruiting | Fukuoka | 810-0001 | Japan |
| Clinical Trial Site | Recruiting | Fukuoka | 812-8582 | Japan |
| Clinical Trial Site | Recruiting | Kagawa | 761-0793 | Japan |
| Clinical Trial Site | Recruiting | Kashihara | 634-8522 | Japan |
| Clinical Trial Site | Recruiting | Kobe | 650-0017 | Japan |
| Clinical Trial Site | Recruiting | Kumamoto | 860-8556 | Japan |
| Clinical Trial Site | Recruiting | Kurume | 830-0011 | Japan |
| Clinical Trial Site | Recruiting | Matsumoto-shi | 390-8621 | Japan |
| Clinical Trial Site | Recruiting | Nagoya | 466-8560 | Japan |
| Clinical Trial Site | Recruiting | Nankoku | 783-0043 | Japan |
| Clinical Trial Site | Recruiting | Niigata | 951-8520 | Japan |
| Clinical Trial Site | Recruiting | Okayama | 700-8558 | Japan |
| Clinical Trial Site | Recruiting | Sapporo | 060-8543 | Japan |
| Clinical Trial Site | Recruiting | Sapporo | 060-8648 | Japan |
| Clinical Trial Site | Recruiting | Sendai | 980-8574 | Japan |
| Clinical Trial Site | Recruiting | Suita | 564-8565 | Japan |
| Clinical Trial Site | Recruiting | Tokyo | 160-8582 | Japan |
| Clinical Trial Site | Recruiting | Kajang | 43000 | Malaysia |
| Clinical Trial Site | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Clinical Trial Site | Recruiting | Eindhoven | 5623 EJ | Netherlands |
| Clinical Trial Site | Recruiting | Groningen | 9713 GZ | Netherlands |
| Clinical Trial Site | Recruiting | Maastricht | 6229 HX | Netherlands |
| Clinical Trial Site | Recruiting | Rotterdam | 3015 GD | Netherlands |
| Clinical Trial Site | Recruiting | Utrecht | 3584 CX | Netherlands |
| Clinical Trial Site | Recruiting | Auckland | 2025 | New Zealand |
| Clinical Trial Site | Recruiting | Christchurch | 8011 | New Zealand |
| Clinical Trial Site | Recruiting | Hamilton | 3204 | New Zealand |
| Clinical Trial Site | Recruiting | Ålesund | 6017 | Norway |
| Clinical Trial Site | Recruiting | Lørenskog | 1478 | Norway |
| Clinical Trial Site | Recruiting | Lodz | 93-338 | Poland |
| Clinical Trial Site | Recruiting | Carnaxide | 2790-134 | Portugal |
| Clinical Trial Site | Recruiting | Creixomil | 4835-044 | Portugal |
| Clinical Trial Site | Recruiting | Leiria | 2410-197 | Portugal |
| Clinical Trial Site | Recruiting | Lisbon | 1169-024 | Portugal |
| Clinical Trial Site | Recruiting | Lisbon | 1649-035 | Portugal |
| Clinical Trial Site | Recruiting | Vila Real | 5000-508 | Portugal |
| Clinical Trial Site | Recruiting | Viseu | 3504-509 | Portugal |
| Clinical Trial Site | Recruiting | Bucharest | 022328 | Romania |
| Clinical Trial Site | Recruiting | Cluj-Napoca | 400001 | Romania |
| Clinical Trial Site | Recruiting | Košice | 040 11 | Slovakia |
| Clinical Trial Site | Recruiting | Incheon | 22332 | South Korea |
| Clinical Trial Site | Recruiting | Seoul | 03080 | South Korea |
| Clinical Trial Site | Recruiting | Seoul | 03722 | South Korea |
| Clinical Trial Site | Recruiting | Seoul | 06351 | South Korea |
| Clinical Trial Site | Recruiting | Seoul | 06591 | South Korea |
| Clinical Trial Site | Recruiting | A Coruña | 15006 | Spain |
| Clinical Trial Site | Recruiting | Barcelona | 08035 | Spain |
| Clinical Trial Site | Recruiting | Barcelona | 08036 | Spain |
| Clinical Trial Site | Recruiting | Bilbao | 48013 | Spain |
| Clinical Trial Site | Recruiting | El Palmar | 30120 | Spain |
| Clinical Trial Site | Recruiting | Huelva | 21005 | Spain |
| Clinical Trial Site | Recruiting | Jaén | 23007 | Spain |
| Clinical Trial Site | Recruiting | L'Hospitalet de Llobregat | 8907 | Spain |
| Clinical Trial Site | Recruiting | Lleida | 25198 | Spain |
| Clinical Trial Site | Recruiting | Madrid | 28046 | Spain |
| Clinical Trial Site | Recruiting | Madrid | 28222 | Spain |
| Clinical Trial Site | Recruiting | Palma de Mallorca | 07198 | Spain |
| Clinical Trial Site | Recruiting | Pamplona | 31008 | Spain |
| Clinical Trial Site | Recruiting | Salamanca | 37007 | Spain |
| Clinical Trial Site | Recruiting | Santiago de Compostela | 15706 | Spain |
| Clinical Trial Site | Recruiting | Valencia | 46010 | Spain |
| Clinical Trial Site | Recruiting | Valencia | 46026 | Spain |
| Clinical Trial Site | Recruiting | Vigo | 36213 | Spain |
| Clinical Trial Site | Recruiting | Gothenburg | 413 45 | Sweden |
| Clinical Trial Site | Recruiting | Lund | 222 42 | Sweden |
| Clinical Trial Site | Recruiting | Solna | 171 76 | Sweden |
| Clinical Trial Site | Recruiting | Basel | 4051 | Switzerland |
| Clinical Trial Site | Recruiting | Geneva | 1205 | Switzerland |
| Clinical Trial Site | Recruiting | Lucerne | 6000 | Switzerland |
| Clinical Trial Site | Recruiting | Sankt Gallen | 9007 | Switzerland |
| Clinical Trial Site | Recruiting | New Taipei City | 220 | Taiwan |
| Clinical Trial Site | Recruiting | Taichung | 40705 | Taiwan |
| Clinical Trial Site | Recruiting | Taipei | 10002 | Taiwan |
| Clinical Trial Site | Recruiting | Taipei | 112 | Taiwan |
| Clinical Trial Site | Recruiting | Ankara | 06170 | Turkey (Türkiye) |
| Clinical Trial Site | Recruiting | Antalya | 07070 | Turkey (Türkiye) |
| Clinical Trial Site | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Clinical Trial Site | Recruiting | Bellshill | ML4 3NJ | United Kingdom |
| Clinical Trial Site | Recruiting | Birmingham | B15 2SQ | United Kingdom |
| Clinical Trial Site | Recruiting | Cardiff | CF15 9SS | United Kingdom |
| Clinical Trial Site | Recruiting | London | NW10 2PB | United Kingdom |
| Clinical Trial Site | Recruiting | London | NW3 2QG | United Kingdom |
| Clinical Trial Site | Recruiting | Manchester | M15 6SE | United Kingdom |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided